FDA · Medical device recall

Prometra Clinician Programmer (Touchscreen) Software version 2.00.29… and 4 more products

June 12, 2019 Class II

Date: June 12, 2019
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: Flowonix Medical Inc
Distribution pattern: US nationwide distribution.

5 products in this recall

Prometra Clinician Programmer (Touchscreen) Software version 2.00.29…

Product: Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
Quantity: 318
Codes and lots: Serial Numbers: A15E0017 A15J0019 A16D0004 RA17B0003 RA17I0001 RA18B0008 RA18D0046 RA18G0074 RA18J0074 A15E0023 A15J0035 A16D0013 RA17B0004 RA17I0002 RA18B0009 RA18D0047 RA18G0079 RA18J0077 A15E0032 A15J0038 A16D0015 RA17B0007 RA17I0003 RA18B0012 RA18D0048 RA18G0080 RA18J0078 A15H0003 A15J0047 A16D0018 RA17C0001 RA17I0004 RA18B0014 RA18D0052 RA18J0001 RA18J0081 A15H0007 A15J0050 A16D0026 RA17C0005 RA17I0005 RA18B0016 RA18D0053 RA18J0002 RA18J050 A15H0031 A15J0051 A16D0032 RA17C0006 RA17I0007 RA18B0018 RA18G0004 RA18J0003 RA18K0003 A15H0038 A15K0018 A16D0033 RA17C0007 RA17I0008 RA18B0020 RA18G0005 RA18J0004 RA18K0004 A15H0039 A15K0036 A16D0036 RA17C0025 RA17I0010 RA18B0023 RA18G0006 RA18J0009 RA18K0007 A15H0054 A15K0042 A16D0037 RA17C0028 RA17I0012 RA18B0026 RA18G0007 RA18J0011 RA18K0008 A15H0067 A15K0045 A16D0039 RA17C0038 RA17I0021 RA18B0027 RA18G0010 RA18J0012 RA18K001 A15I0005 A15K0046 A16D0040 RA17C0039 RA17I0024 RA18B0030 RA18G0011 RA18J0013 RA18K0010 A15I0015 A15K0053 A16D0042 RA17C0041 RA17J0003 RA18B0033 RA18G0012 RA18J0014 RA18L0001 A15I0019 A15K0055 A16D0046 RA17F0006 RA17J0004 RA18B0036 RA18G0017 RA18J0015 RA18L0002 A15I0020 A15L0003 A16D0047 RA17F0007 RA17J0005 RA18B0037 RA18G0021 RA18J0016 RA18L0004 A15I0039 A15L0029 A16D0049 RA17F0008 RA17J0008 RA18B0040 RA18G0022 RA18J0019 RA18L0007 A15I0043 A15L0067 A16D0051 RA17F0009 RA17J0011 RA18B0042 RA18G0023 RA18J0021 RA18L0010 A15I0046 A15L0068 A16D0058 RA17F0011 RA17J0016 RA18B0047 RA18G0025 RA18J0022 RA18L019 A15I0049 A15L0069 A16D0073 RA17F0012 RA17K0002 RA18B0053 RA18G0026 RA18J0023 RA18L020 A15I0058 A15L0070 A16D0074 RA17F0018 RA17K0008 RA18B0055 RA18G0027 RA18J0025 RA18L021 A15I0062 A16B0002 A17C0011 RA17F0024 RA17K0009 RA18C0003 RA18G0031 RA18J0030 RA18L022 A15I0067 A16B0003 A17D0009 RA17F0025 RA17L0001 RA18D0002 RA18G0032 RA18J0031 RA18L023 A15I0068 A16B0008 A17D0010 RA17F0028 RA17L0002 RA18D0003 RA18G0033 RA18J0034 RA18L024 A15I0070 A16C0006 A17E0003 RA17F0030 RA17L0003 RA18D0006 RA18G0040 RA18J0038 RA18L027 A15I0072 A16C0011 A17E0008 RA17F0032 RA17L0004 RA18D0007 RA18G0042 RA18J0039 RA18L028 A15I0073 A16C0012 A17E0009 RA17F0033 RA17L0008 RA18D0010 RA18G0043 RA18J0040 RA18L029 A15I0075 A16C0017 A17F0001 RA17F0037 RA17L0009 RA18D0022 RA18G0044 RA18J0041 RA18L030 A15I0089 A16C0024 A17F0003 RA17F0038 RA17L0010 RA18D0024 RA18G0045 RA18J0046 RA18L031 A15I0139 A16C0028 A17F0004 RA17F0039 RA17L0012 RA18D0026 RA18G0050 RA18J0048 RA18L032 A15I0140 A16C0030 A17F0005 RA17F0041 RA17L0014 RA18D0028 RA18G0055 RA18J0053 RA18L033 A15J0002 A16C0038 RA17A0002 RA17F0042 RA17L0022 RA18D0033 RA18G0056 RA18J0063 RA18L034 A15J0004 A16C0041 RA17A0004 RA17F0043 RA18B0001 RA18D0039 RA18G0058 RA18J0064 RA18L036 A15J0006 A16C0044 RA17A0005 RA17G0005 RA18B0002 RA18D0040 RA18G0062 RA18J0068 RA18L051 A15J0010 A16C0060 RA17A0011 RA17G0006 RA18B0004 RA18D0041 RA18G0064 RA18J0070 RA18L052 A15J0011 A16C0063 RA17A0035 RA17G0016 RA18B0006 RA18D0043 RA18G0065 RA18J0071 RA18L053 A15J0017 A16C0072 RA17A0041 RA17G0017 RA18B0007 RA18D0045 RA18G0068 RA18J0073 RA18L054 RA18L057 RA18L055 RA18L056
Recall started: March 21, 2019
Device type: Pump, Infusion, Implanted, Programmable
Root cause (FDA): Software change control
What the company told customers: On March 21, 2019, the firm issued Urgent Recall Notices to customers to inform them of the product issue. In May 2019, the firm sent updated communications to customers: Healthcare providers who have Clinician Programmers with SW 2.00.29 were sent a follow-up recall letter. This letter included the information that the pump stop following "Error Code 115" will only occur after the Bridge or Demand Bolus is complete, which could take up to seventy-two (72 hours). In addition, in the event of any cause of an "Error Code 115", the pump sounds a one-beep alarm and then shuts down. This behavior differs from the Instructions for Use, which state that the pump will sound three long (half second) beeps every 30 minutes for all critical errors. As it is unlikely that the patient will notice the single beep, there may be a significant delay in the patient becoming aware that the pump has stopped delivering therapy which may in turn delay resumption of drug therapy. Healthcare providers who have Clinician Programmers with any other version of the software and the implant pumps received a Corrective Action Notice. This notice included the information from the preceding paragraph, noting the discrepant alarm behavior for "Error Code 115" could be missed by the patient. Customers with the new Prometra Clinician Programmer software (v. 2.00.29) were asked to do the following: 1. STOP using the Periodic Flow or Multiple Rates flow mode functions in combination with a Bridge or Demand Bolus using the Clinician Programmer with Software Version 2.00.29. The error only occurs when these functions are used together. a. In the event that a Bridge or Demand Bolus is needed, convert the patient to Constant Flow Mode, then program the Bridge or Demand Bolus as needed (instructions for use PL-11803-04, page 30). Once the bolus is complete, revisit the patient or have him/her return to your clinic for programming back into their original flow mode. 2. IDENTIFY
Recall number: Z-1712-2019

Prometra Programmer (Grand Prime) Software version 2.00.29…

Product: Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
Quantity: 40
Codes and lots: Software v.2.00.29 Serial numbers: D18L0003 D18L0022 D18L0013 D18L0035 D18L0004 D18L0025 D18L0014 D18L0036 D18L0006 D18L0026 D18L0015 D18L0037 D18L0010 D18L0027 D18L0016 D18L0038 D18L0009 D18L0028 D18L0017 D18L0034 D18L0008 D18L0029 D18L0018 D18L0039 D18L0007 D18L0030 D18L0019 D18L0040 D18L0011 D18L0031 D18L0021 D18L0041 D18L0005 D18L0032 D18L0023 D18L0042 D18L0012 D18L0033 D18L0024 D18L0020
Recall started: March 21, 2019
Device type: Pump, Infusion, Implanted, Programmable
Root cause (FDA): Software change control
What the company told customers: On March 21, 2019, the firm issued Urgent Recall Notices to customers to inform them of the product issue. In May 2019, the firm sent updated communications to customers: Healthcare providers who have Clinician Programmers with SW 2.00.29 were sent a follow-up recall letter. This letter included the information that the pump stop following "Error Code 115" will only occur after the Bridge or Demand Bolus is complete, which could take up to seventy-two (72 hours). In addition, in the event of any cause of an "Error Code 115", the pump sounds a one-beep alarm and then shuts down. This behavior differs from the Instructions for Use, which state that the pump will sound three long (half second) beeps every 30 minutes for all critical errors. As it is unlikely that the patient will notice the single beep, there may be a significant delay in the patient becoming aware that the pump has stopped delivering therapy which may in turn delay resumption of drug therapy. Healthcare providers who have Clinician Programmers with any other version of the software and the implant pumps received a Corrective Action Notice. This notice included the information from the preceding paragraph, noting the discrepant alarm behavior for "Error Code 115" could be missed by the patient. Customers with the new Prometra Clinician Programmer software (v. 2.00.29) were asked to do the following: 1. STOP using the Periodic Flow or Multiple Rates flow mode functions in combination with a Bridge or Demand Bolus using the Clinician Programmer with Software Version 2.00.29. The error only occurs when these functions are used together. a. In the event that a Bridge or Demand Bolus is needed, convert the patient to Constant Flow Mode, then program the Bridge or Demand Bolus as needed (instructions for use PL-11803-04, page 30). Once the bolus is complete, revisit the patient or have him/her return to your clinic for programming back into their original flow mode. 2. IDENTIFY
Recall number: Z-1713-2019

Prometra Programmable Pump…

Product: Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
Quantity: 809
Codes and lots: Serial Numbers: 10AX4A03 10BY4A40 10EY4A35 10GX4A83 10HW4A31 10HY4C11 10JW4A28 10KW4A42 10KX4A48 10AX4A04 10BY4A41 10EY4A36 10GX4A84 10HW4A45 10HY4C12 10JW4A29 10KW4A43 10KX4A49 10AX4A06 10BY4A42 10EY4A37 10GX4A85 10HW4A57 10HY4C13 10JW4A30 10KW4A44 10KX4A50 10AX4A10 10BY4A44 10EY4A38 10GX4A86 10HY4A77 10HY4C15 10JW4A31 10KW4A45 10KX4A52 10AX4A12 10BY4A45 10EY4A40 10GX4A87 10HY4A78 10HY4C16 10JW4A32 10KW4A46 10KX4A56 10AX4A14 10BY4A46 10EY4A41 10GX4A88 10HY4A79 10HY4C17 10JW4A33 10KW4A47 10KX4A57 10AX4A21 10BY4A47 10EY4A43 10GX4A89 10HY4A80 10HY4C18 10JW4A34 10KW4A48 10KX4A58 10AX4A22 10BY4A48 10EY4A44 10GX4A92 10HY4A81 10HY4C19 10JW4A35 10KW4A49 10KX4A59 10AX4A23 10BY4A49 10EY4A45 10GX4A94 10HY4A82 10HY4C20 10JW4A36 10KW4A50 10KX4A60 10AX4A28 10BY4A50 10EY4A46 10GX4A96 10HY4A83 10HY4C22 10JW4A37 10KW4A51 10KX4A62 10AX4A30 10BY4A51 10EY4A47 10GX4A97 10HY4A84 10HY4C23 10JW4A38 10KW4A52 10KX4A63 10AX4A36 10BY4A52 10EY4A48 10GX4A98 10HY4A85 10HY4C26 10JW4A39 10KW4A53 10KX4A64 10AX4A37 10BY4A53 10EY4A51 10GX4A99 10HY4A87 10HY4C27 10JW4A40 10KW4A54 10KX4A65 10AX4A39 10BY4A54 10EY4A52 10GX4B02 10HY4A90 10HY4C28 10JW4A41 10KW4A55 10KX4A66 10AX4A42 10BY4A55 10EY4A53 10GX4B03 10HY4A91 10HY4C29 10JW4A42 10KW4A56 10KX4A67 10AX4A48 10BY4A56 10EY4A54 10GX4B04 10HY4A92 10HY4C30 10JW4A43 10KW4A57 10KX4A68 10AX4A51 10BY4A57 10EY4A55 10GX4B05 10HY4A95 10HY4C32 10JW4A44 10KW4A58 10KX4A69 10AX4A73 10BY4A58 10EY4A56 10GX4B06 10HY4A97 10HY4C34 10JW4A45 10KW4A59 10KX4A70 10AX4A74 10BY4A59 10EY4A58 10GX4B07 10HY4A98 10HY4C35 10JW4A46 10KW4A60 10KX4A71 10AX4A76 10BY4A60 10EY4A59 10GX4B08 10HY4B01 10HY4C36 10JW4A47 10KW4A61 10KX4A72 10AX4A81 10BZ4A24 10EY4A60 10GX4B09 10HY4B02 10HY4C37 10JW4A48 10KW4A63 10KX4A73 10AX4A83 10BZ4A26 10EY4A61 10GX4B10 10HY4B03 10HY4C39 10JY4A01 10KW4A64 10KX4A74 10AX4A85 10BZ4A32 10EY4A62 10GX4B11 10HY4B05 10HY4C40 10JY4A03 10KW4A65 10KX4A76 10AX4A87 10BZ4A46 10EY4A63 10GX4B12 10HY4B07 10HY4C41 10JY4A06 10KW4A66 10KX4A77 10AX4A88 10BZ4A70 10EY4A64 10GX4B13 10HY4B08 10HY4C42 10JY4A07 10KW4A67 10KX4A78 10AX4A89 10BZ4A71 10EY4A65 10GX4B14 10HY4B10 10HY4C46 10JY4A09 10KW4A68 10KX4A79 10AX4A93 10CZ4A02 10EY4A66 10GX4B15 10HY4B12 10HY4C47 10JY4A10 10KW4A70 10KX4A80 10AX4A95 10CZ4A03 10EY4A67 10GX4B16 10HY4B16 10IY2A05 10JY4A15 10KW4A71 10KX4A81 10AX4A96 10CZ4A04 10EY4A69 10GX4B21 10HY4B17 10IY2A26 10JY4A16 10KW4A72 10KX4A82 10AX4A98 10DX4A03 10EY4A70 10GX4B22 10HY4B18 10IY4A01 10JY4A18 10KW4A73 10KX4A85 10AX4B06 10DX4A07 10EY4A72 10GX4B25 10HY4B19 10IY4A02 10JY4A20 10KW4A74 10KY4A02 10AX4B08 10DX4A09 10EY4A73 10GY4A02 10HY4B20 10IY4A03 10JY4A21 10KW4A75 10KY4A03 10AX4B09 10DX4A10 10EY4A74 10GY4A03 10HY4B22 10IY4A04 10JY4A25 10KW4A76 10KY4A04 10AX4B16 10DX4A13 10EY4A75 10GY4A05 10HY4B23 10IY4A05 10JY4A28 10KW4A77 10KY4A06 10AX4B17 10DX4A21 10EY4A76 10GY4A06 10HY4B24 10IY4A09 10JY4A29 10KW4A78 10KY4A07 10DX4A24 10EY4A81 10GY4A11 10HY4B26 10IY4A11 10KV4A01 10KW4A80 10KY4A10 10AX4B26 10DX4A32 10EY4A82 10GY4A12 10HY4B27 10IY4A13 10KW4A01 10KW4A81 10KY4A11 10AX4B27 10DX4A33 10EY4A83 10GY4A13 10HY4B28 10IY4A15 10KW4A02 10KW4A83 10KY4A12 10AX4B29 10DX4A34 10EY4A87 10GY4A14 10HY4B29 10IY4A17 10KW4A03 10KW4A84 10KY4A13 10AX4B53 10DX4A41 10EY4A88 10GY4A15 10HY4B30 10IY4A19 10KW4A04 10KW4A85 10KY4A15 10AX4B78 10DX4A44 10EY4A89 10GY4A16 10HY4B33 10IY4A25 10KW4A05 10KW4A86 10KY4A17 10AX4B79 10DX4A48 10EY4A90 10GY4A18 10HY4B34 10IY4A26 10KW4A06 10KW4A87 10KY4A18 10AX4B80 10DX4A52 10EY4A92 10GY4A19 10HY4B35 10IY4A27 10KW4A07 10KW4A88 10KY4A20 10AX4B81 10DX4A60 10EY4A93 10GY4A20 10HY4B36 10IY4A28 10KW4A08 10KW4A89 10KY4A21 10AX4B82 10DX4A62 10EY4A94 10GY4A21 10HY4B37 10IY4A29 10KW4A09 10KW4A90 10KY4A25 10AX4B84 10DX4A65 10EY4A95 10GY4A22 10HY4B40 10IY4A31 10KW4A10 10KW4A91 10KY4A26 10AX4B85 10DX4A67 10EY4A96 10GY4A23 10HY4B41 10IY4A33 10KW4A101 10KW4A92 10KY4A27 10AX4B86 10DX4A71 10EY4A97 10GY4A25 10HY4B42 10IY4A37 10KW4A103 10KW4A93 10KY4A30 10AX4B88 10DX4A74 10EY4A98 10GY4A26 10HY4B43 10IY4A38 10KW4A104 10KW4A94 10KY4A31 10AX4B90 10DX4A79 10EY4A99 10GY4A27 10HY4B44 10IY4A41 10KW4A105 10KW4A95 10KY4A33 10AX4B91 10DX4A82 10GX4A03 10GY4A28 10HY4B45 10IY4A43 10KW4A106 10KW4A96 10KY4A35 10AX4B92 10DX4A85 10GX4A04 10GY4A30 10HY4B48 10IY4A44 10KW4A108 10KW4A98 10KY4A36 10AX4B94 10DX4A89 10GX4A08 10GY4A31 10HY4B49 10IY4A46 10KW4A109 10KW4A99 10KY4A37 10AX4B96 10DX4A95 10GX4A09 10GY4A32 10HY4B50 10IY4A50 10KW4A11 10KX4A01 10KY4A39 10AX4B97 10DX4A96 10GX4A10 10GY4A34 10HY4B51 10IY4A51 10KW4A110 10KX4A02 10KY4A40 10AZ4A08 10DX4A98 10GX4A12 10GY4A35 10HY4B53 10IY4A52 10KW4A111 10KX4A04 10KY4A41 10AZ4A10 10DX4A99 10GX4A14 10GY4A36 10HY4B54 10IY4A54 10KW4A113 10KX4A05 10KY4A43 10AZ4A12 10DX4B02 10GX4A15 10GY4A39 10HY4B55 10IY4A56 10KW4A116 10KX4A06 10KY4A44 10AZ4A14 10DX4B03 10GX4A16 10GY4A40 10HY4B56 10IY4A58 10KW4A117 10KX4A07 10KY4A45 10AZ4A15 10DX4B07 10GX4A19 10GY4A41 10HY4B62 10IY4A59 10KW4A119 10KX4A08 10KY4A47 10AZ4A18 10DX4B15 10GX4A21 10GY4A42 10HY4B63 10IY4A60 10KW4A12 10KX4A09 10KY4A50 10AZ4A19 10DX4B17 10GX4A30 10GY4A44 10HY4B65 10IY4A61 10KW4A120 10KX4A10 10KY4A51 10AZ4A22 10DX4B21 10GX4A31 10GY4A45 10HY4B66 10IY4A62 10KW4A121 10KX4A11 10KY4A60 10AZ4A24 10DX4B25 10GX4A32 10GY4A47 10HY4B69 10JW4A01 10KW4A122 10KX4A12 10KY4A61 10AZ4A31 10DX4B26 10GX4A33 10GY4A49 10HY4B70 10JW4A02 10KW4A123 10KX4A13 10KY4A62 10AZ4A33 10EY4A01 10GX4A34 10GY4A50 10HY4B74 10JW4A03 10KW4A125 10KX4A14 10KY4A63 10AZ4A43 10EY4A02 10GX4A37 10GY4A51 10HY4B76 10JW4A04 10KW4A13 10KX4A15 10KY4A64 10AZ4A54 10EY4A03 10GX4A38 10GY4A52 10HY4B78 10JW4A05 10KW4A14 10KX4A16 10KY4A65 10AZ4A57 10EY4A04 10GX4A39 10GY4A53 10HY4B79 10JW4A06 10KW4A15 10KX4A17 10KY4A67 10AZ4A59 10EY4A05 10GX4A40 10GY4A54 10HY4B80 10JW4A07 10KW4A16 10KX4A18 10KY4A68 10AZ4A61 10EY4A08 10GX4A44 10GY4A55 10HY4B81 10JW4A08 10KW4A17 10KX4A19 10KY4A69 10AZ4A65 10EY4A11 10GX4A45 10GY4A56 10HY4B83 10JW4A09 10KW4A18 10KX4A20 10KY4A71 10AZ4A70 10EY4A13 10GX4A46 10GY4A57 10HY4B84 10JW4A10 10KW4A19 10KX4A21 10KY4A72 10AZ4A73 10EY4A14 10GX4A47 10GY4A58 10HY4B85 10JW4A11 10KW4A20 10KX4A22 10KY4A75 10BY4A25 10EY4A15 10GX4A48 10GY4A59 10HY4B86 10JW4A12 10KW4A21 10KX4A25 10KY4A78 10BY4A26 10EY4A16 10GX4A57 10GY4A60 10HY4B90 10JW4A13 10KW4A23 10KX4A26 10KY4A79 10BY4A27 10EY4A17 10GX4A62 10GY4A61 10HY4B91 10JW4A14 10KW4A24 10KX4A27 10KY4A82 10GX4A65 10GY4A63 10HY4B96 10JW4A16 10KW4A26 10KX4A29 10KY4A84 10BY4A30 10EY4A21 10GX4A67 10GY4A64 10HY4B97 10JW4A17 10KW4A27 10KX4A30 10KY4A86 10BY4A31 10EY4A22 10GX4A69 10GY4A65 10HY4B99 10JW4A18 10KW4A29 10KX4A32 10KY4A87 10BY4A32 10EY4A24 10GX4A70 10GY4A66 10HY4C01 10JW4A19 10KW4A30 10KX4A39 10KY4A90 10BY4A33 10EY4A25 10GX4A71 10GY4A67 10HY4C02 10JW4A20 10KW4A31 10KX4A40 10KY4A91 10BY4A34 10EY4A26 10GX4A72 10GY4A70 10HY4C03 10JW4A21 10KW4A32 10KX4A41 10KY4A92 10BY4A35 10EY4A27 10GX4A73 10GY4A71 10HY4C04 10JW4A22 10KW4A35 10KX4A42 10KY4A93 10BY4A36 10EY4A28 10GX4A74 10GY4A72 10HY4C06 10JW4A24 10KW4A38 10KX4A43 10KY4A94 10BY4A37 10EY4A29 10GX4A76 10GY4A73 10HY4C07 10JW4A25 10KW4A39 10KX4A44 10KY4A97 10BY4A38 10EY4A31 10GX4A81 10GY4A74 10HY4C08 10JW4A26 10KW4A40 10KX4A46 10KY4A99 10BY4A39 10EY4A33 10GX4A82 10HW4A29 10HY4C09 10JW4A27 10KW4A41 10KX4A47
Recall started: March 21, 2019
Device type: Pump, Infusion, Implanted, Programmable
Root cause (FDA): Software change control
What the company told customers: On March 21, 2019, the firm issued Urgent Recall Notices to customers to inform them of the product issue. In May 2019, the firm sent updated communications to customers: Healthcare providers who have Clinician Programmers with SW 2.00.29 were sent a follow-up recall letter. This letter included the information that the pump stop following "Error Code 115" will only occur after the Bridge or Demand Bolus is complete, which could take up to seventy-two (72 hours). In addition, in the event of any cause of an "Error Code 115", the pump sounds a one-beep alarm and then shuts down. This behavior differs from the Instructions for Use, which state that the pump will sound three long (half second) beeps every 30 minutes for all critical errors. As it is unlikely that the patient will notice the single beep, there may be a significant delay in the patient becoming aware that the pump has stopped delivering therapy which may in turn delay resumption of drug therapy. Healthcare providers who have Clinician Programmers with any other version of the software and the implant pumps received a Corrective Action Notice. This notice included the information from the preceding paragraph, noting the discrepant alarm behavior for "Error Code 115" could be missed by the patient. Customers with the new Prometra Clinician Programmer software (v. 2.00.29) were asked to do the following: 1. STOP using the Periodic Flow or Multiple Rates flow mode functions in combination with a Bridge or Demand Bolus using the Clinician Programmer with Software Version 2.00.29. The error only occurs when these functions are used together. a. In the event that a Bridge or Demand Bolus is needed, convert the patient to Constant Flow Mode, then program the Bridge or Demand Bolus as needed (instructions for use PL-11803-04, page 30). Once the bolus is complete, revisit the patient or have him/her return to your clinic for programming back into their original flow mode. 2. IDENTIFY
Recall number: Z-1714-2019

Prometra II Programmable Pump…

Product: Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
Quantity: 6445
Codes and lots: Serial Numbers: 10AA4A01X 10BC4A84X 10CC4C06X 10EB4A27X 10GB4A05X 10HA4E28X 10IA4B69X 10JA4B52X 10KB4A76X 10AA4A02X 10BC4A86X 10CC4C07X 10EB4A28X 10GB4A07X 10HA4E29X 10IA4B70X 10JA4B53X 10KB4A77X 10AA4A03X 10BC4A87X 10CC4C08X 10EB4A29X 10GB4A08X 10HA4E30X 10IA4B71X 10JA4B54X 10KB4A78X 10AA4A04X 10BC4A88X 10CC4C09X 10EB4A30X 10GB4A10X 10HA4E31X 10IA4B72X 10JA4B55X 10KB4A79X 10AA4A05X 10BC4A89X 10CC4C10X 10EB4A31X 10GB4A11X 10HB4A01X 10IA4B73X 10JA4B56X 10KB4A80X 10AA4A06X 10BC4A90X 10CC4C11X 10EB4A33X 10GB4A13X 10HB4A02X 10IA4B74X 10JA4B57X 10KB4A81X 10AA4A07X 10BC4A92X 10CC4C12X 10EB4A34X 10GB4A14X 10HB4A03X 10IA4B75X 10JA4B58X 10KB4A82X 10AA4A08X 10BC4A94X 10CC4C13X 10EB4A35X 10GB4A15X 10HB4A04X 10IA4B76X 10JA4B59X 10KB4A84X 10AA4A09X 10BC4A96X 10CC4C14X 10EB4A36X 10GB4A17X 10HB4A05X 10IB4A31X 10JA4B60X 10KB4A86X 10AA4A10X 10BC4A97X 10CC4C15X 10EB4A39X 10GB4A18X 10HB4A06X 10IB4A32X 10JA4B61X 10KB4A87X 10AA4A11X 10BC4A98X 10CC4C16X 10EB4A40X 10GB4A19X 10HB4A07X 10IB4A33X 10JB4A01X 10KB4A88X 10AA4A12X 10BC4A99X 10CC4C17X 10EB4A41X 10GB4A20X 10HB4A08X 10IB4A34X 10JB4A02X 10KB4A89X 10AA4A13X 10BC4B01X 10CC4C18X 10EB4A42X 10GB4A21X 10HB4A09X 10IB4A35X 10JB4A03X 10KB4A90X 10AA4A14X 10BC4B02X 10CC4C19X 10EB4A43X 10GB4A22X 10HB4A10X 10IB4A36X 10JB4A04X 10KB4A91X 10AA4A15X 10BC4B04X 10CC4C20X 10EB4A44X 10GB4A23X 10HB4A11X 10IB4A38X 10JB4A05X 10KB4A93X 10AA4A16X 10BC4B05X 10CC4C21X 10EB4A45X 10GB4A24X 10HB4A12X 10IB4A39X 10JB4A06X 10KB4A94X 10AA4A17X 10BC4B06X 10CC4C22X 10EB4A46X 10GB4A27X 10HB4A13X 10IB4A40X 10JB4A07X 10KB4A95X 10AA4A18X 10BC4B07X 10CC4C23X 10EB4A47X 10GB4A28X 10HB4A14X 10IB4A41X 10JB4A08X 10KB4A96X 10AA4A19X 10BC4B08X 10CC4C24X 10EB4A48X 10GB4A29X 10HB4A15X 10IB4A42X 10JB4A09X 10KB4A97X 10AA4A20X 10BC4B09X 10CC4C25X 10EB4A49X 10GB4A30X 10HB4A16X 10IB4A43X 10JB4A10X 10KB4A99X 10AA4A32X 10BC4B22X 10CC4C37X 10EB4A63X 10GB4A44X 10HB4A28X 10IB4A58X 10JB4A23X 10KB4B18X 10AA4A33X 10BC4B24X 10CC4C38X 10EB4A64X 10GB4A45X 10HB4A29X 10IB4A59X 10JB4A24X 10KB4B19X 10AA4A34X 10BC4B25X 10CC4C39X 10EB4A65X 10GB4A46X 10HB4A30X 10IB4A60X 10JB4A25X 10KB4B21X 10AA4A35X 10BC4B26X 10CC4C40X 10EB4A66X 10GB4A47X 10HB4A31X 10IB4A61X 10JB4A26X 10KB4B22X 10AA4A36X 10BC4B27X 10CC4C41X 10EB4A67X 10GB4A48X 10HB4A32X 10IB4A62X 10JB4A27X 10KB4B23X 10AA4A37X 10BC4B28X 10CC4C42X 10EB4A68X 10GB4A49X 10HB4A33X 10IB4A63X 10JB4A29X 10KB4B24X 10AA4A38X 10BC4B29X 10CC4C43X 10EB4A69X 10GB4A51X 10HB4A34X 10IB4A64X 10JB4A30X 10KB4B25X 10AA4A39X 10BC4B30X 10CC4C44X 10EB4A70X 10GB4A52X 10HB4A35X 10IB4A65X 10JB4A31X 10KB4B26X 10AA4A40X 10BC4B31X 10CC4C45X 10EB4A71X 10GB4A53X 10HB4A36X 10IB4A66X 10JB4A32X 10KB4B27X 10AA4A41X 10BC4B32X 10CC4C46X 10EB4A72X 10GB4A54X 10HB4A37X 10IB4A67X 10JB4A33X 10KB4B28X 10AA4A42X 10BC4B33X 10CC4C47X 10EB4A73X 10GB4A55X 10HB4A38X 10IB4A68X 10JB4A34X 10KB4B29X 10AA4A43X 10BC4B34X 10CC4C48X 10EB4A74X 10GB4A56X 10HB4A39X 10IB4A69X 10JB4A35X 10KB4B30X 10AA4A44X 10BC4B35X 10CC4C49X 10EB4A75X 10GB4A57X 10HB4A40X 10IB4A70X 10JB4A36X 10KB4B31X 10AA4A45X 10BC4B36X 10CC4C50X 10EB4A76X 10GB4A60X 10HB4A41X 10IB4A71X 10JB4A37X 10KB4B32X 10AA4A46X 10BC4B37X 10CC4C51X 10EB4A77X 10GB4A61X 10HB4A42X 10IB4A72X 10JB4A38X 10KB4B33X 10AA4A47X 10BC4B38X 10CC4C52X 10EB4A78X 10GB4A62X 10HB4A43X 10IB4A73X 10JB4A39X 10KB4B34X 10AA4A48X 10BC4B39X 10CZ4A76X 10EB4A79X 10GB4A63X 10HB4A44X 10IB4A74X 10JB4A40X 10KB4B35X 10AA4A49X 10BC4B40X 10CZ4A77X 10EB4A80X 10GB4A64X 10HB4A45X 10IB4A75X 10JB4A41X 10KB4B36X 10AA4A50X 10BC4B41X 10CZ4A78X 10EB4A81X 10GB4A65X 10HB4A46X 10IB4A76X 10JB4A42X 10KB4B37X 10AA4A51X 10BC4B42X 10CZ4A79X 10EB4A82X 10GB4A66X 10HB4A47X 10IB4A77X 10JB4A43X 10KB4B38X 10AA4A52X 10BC4B43X 10CZ4A80X 10EB4A84X 10GB4A67X 10HB4A48X 10IB4A79X 10JB4A44X 10KB4B39X 10AA4A53X 10BC4B44X 10CZ4A81X 10EB4A85X 10GB4A68X 10HB4A49X 10IB4A80X 10JB4A45X 10KB4B40X 10AA4A54X 10BC4B46X 10CZ4A82X 10EB4A86X 10GB4A69X 10HB4A51X 10IB4A81X 10JB4A46X 10KB4B41X 10AA4A55X 10BC4B52X 10CZ4A83X 10EB4A88X 10GB4A70X 10HB4A52X 10IB4A82X 10JB4A47X 10KB4B42X 10AA4A56X 10BC4B53X 10CZ4A84X 10EB4A89X 10GB4A71X 10HB4A53X 10IB4A83X 10JB4A48X 10KB4B43X 10AA4A57X 10BC4B55X 10CZ4A85X 10EB4A91X 10GB4A72X 10HB4A54X 10IB4A84X 10JB4A49X 10KB4B44X 10AA4A58X 10BC4B56X 10CZ4A86X 10EB4A92X 10GB4A73X 10HB4A55X 10IB4A86X 10JB4A50X 10KB4B45X 10AA4A59X 10BC4B57X 10CZ4A87X 10EB4A93X 10GB4A74X 10HB4A56X 10IB4A87X 10JB4A51X 10KB4B46X 10AA4A60X 10BC4B58X 10CZ4A88X 10EB4A94X 10GB4A75X 10HB4A57X 10IB4A88X 10JB4A52X 10KB4B47X 10AA4A61X 10BC4B59X 10CZ4A89X 10EB4A95X 10GB4A76X 10HB4A59X 10IB4A89X 10JB4A53X 10KB4B48X 10AA4A62X 10BC4B60X 10CZ4A90X 10EB4A96X 10GB4A78X 10HB4A60X 10IB4A90X 10JB4A54X 10KB4B49X 10AA4A63X 10BC4B61X 10CZ4A91X 10EB4A99X 10GB4A79X 10HB4A61X 10IB4A91X 10JB4A55X 10KB4B50X 10AA4A64X 10BC4B62X 10CZ4A92X 10EB4B01X 10GB4A80X 10HB4A62X 10IB4A92X 10JB4A56X 10KB4B51X 10AA4A65X 10BC4B63X 10CZ4A93X 10EB4B02X 10GB4A81X 10HB4A63X 10IB4A93X 10JB4A58X 10KB4B52X 10AA4A66X 10BC4B64X 10CZ4A94X 10EB4B04X 10GB4A82X 10HB4A64X 10IB4A94X 10JB4A59X 10KB4B53X 10AA4A67X 10BC4B65X 10CZ4A95X 10EB4B05X 10GB4A83X 10HB4A65X 10IB4A95X 10JB4A60X 10KB4B54X 10AA4A68X 10BC4B66X 10CZ4A96X 10EB4B06X 10GB4A84X 10HB4A66X 10IB4A96X 10JB4A61X 10KB4B55X 10AA4A69X 10BC4B67X 10CZ4A97X 10EB4B07X 10GB4A85X 10HB4A67X 10IB4A97X 10JB4A62X 10KB4B56X 10AA4A70X 10BC4B68X 10CZ4A98X 10EB4B08X 10GB4A86X 10HB4A68X 10IB4A98X 10JB4A63X 10KB4B57X 10AA4A71X 10BC4B69X 10CZ4A99X 10EB4B09X 10GB4A87X 10HB4A69X 10IB4A99X 10JB4A64X 10KB4B58X 10AA4A72X 10BC4B70X 10CZ4B01X 10EB4B10X 10GB4A88X 10HB4A70X 10IB4B01X 10JB4A65X 10KB4B59X 10AA4A73X 10BC4B71X 10CZ4B02X 10EB4B11X 10GB4A89X 10HB4A71X 10IB4B02X 10JB4A66X 10KB4B60X 10AA4A74X 10BC4B72X 10CZ4B03X 10EB4B12X 10GB4A90X 10HB4A72X 10IB4B03X 10JB4A67X 10KB4B61X 10AA4A75X 10BC4B73X 10CZ4B04X 10EB4B13X 10GB4A91X 10HB4A73X 10IB4B04X 10JB4A68X 10KB4B62X 10AA4A76X 10BC4B74X 10CZ4B05X 10EB4B14X 10GB4A92X 10HB4A75X 10IB4B05X 10JB4A69X 10KB4B63X 10AA4A77X 10BC4B75X 10CZ4B06X 10EB4B15X 10GB4A93X 10HB4A76X 10IB4B06X 10JB4A72X 10KB4B64X 10AA4A78X 10BC4B76X 10CZ4B07X 10EB4B17X 10GB4A94X 10HB4A77X 10IB4B07X 10JB4A73X 10KB4B66X 10AA4A79X 10BC4B77X 10CZ4B08X 10EB4B18X 10GB4A95X 10HB4A78X 10IB4B08X 10JB4A74X 10KB4B67X 10AA4A80X 10BC4B78X 10CZ4B09X 10EB4B19X 10GB4A96X 10HB4A79X 10IB4B09X 10JB4A75X 10KB4B68X 10AA4A81X 10BC4B79X 10CZ4B10X 10EB4B20X 10GB4A97X 10HB4A80X 10IB4B11X 10JB4A76X 10KB4B69X 10AA4A82X 10BC4B80X 10CZ4B11X 10EB4B21X 10GB4A99X 10HB4A81X 10IB4B12X 10JB4A77X 10KB4B70X 10AA4A83X 10BC4B81X 10CZ4B12X 10EB4B22X 10GB4B01X 10HB4A82X 10IB4B13X 10JB4A78X 10KB4B71X 10AA4A84X 10BC4B82X 10CZ4B13X 10EB4B23X 10GB4B02X 10HB4A84X 10IB4B14X 10JB4A79X 10KB4B72X 10AA4A85X 10BC4B83X 10CZ4B14X 10EB4B24X 10GB4B05X 10HB4A85X 10IB4B15X 10JB4A80X 10KB4B73X 10AA4A86X 10BC4B84X 10CZ4B15X 10EB4B25X 10GB4B06X 10HB4A86X 10IB4B16X 10JB4A81X 10KB4B74X 10AA4A87X 10BC4B85X 10CZ4B16X 10EB4B26X 10GB4B07X 10HB4A87X 10IB4B17X 10JB4A82X 10KB4B75X 10AA4A88X 10BC4B86X 10CZ4B17X 10EB4B27X 10GB4B08X 10HB4A88X 10IB4B18X 10JB4A83X 10KB4B76X 10AA4A90X 10BC4B87X 10CZ4B18X 10EB4B28X 10GB4B09X 10HB4A89X 10IB4B19X 10JB4A84X 10KC4A00X 10AB4A01X 10BC4B88X 10CZ4B19X 10EB4B30X 10GB4B10X 10HB4A91X 10IB4B20X 10JB4A85X 10KC4A01X 10AB4A02X 10BC4B89X 10CZ4B20X 10EB4B32X 10GB4B11X 10HB4A92X 10IB4B21X 10JB4A86X 10KC4A02X 10AB4A03X 10BC4B90X 10CZ4B21X 10EB4B33X 10GB4B12X 10HB4A93X 10IB4B22X 10JB4A87X 10KC4A03X 10AB4A04X 10BC4B91X 10CZ4B22X 10EB4B34X 10GB4B14X 10HB4A95X 10IB4B23X 10JB4A88X 10KC4A04X 10AB4A05X 10BC4B92X 10CZ4B23X 10EB4B35X 10GB4B15X 10HB4A96X 10IB4B24X 10JB4A89X 10KC4A06X 10AB4A06X 10BC4B93X 10CZ4B24X 10EB4B36X 10GB4B16X 10HB4A97X 10IB4B25X 10JB4A91X 10KC4A07X 10AB4A07X 10BC4B94X 10CZ4B25X 10EB4B37X 10GB4B17X 10HB4A98X 10IB4B27X 10JB4A92X 10KC4A08X 10AB4A08X 10BC4B95X 10CZ4B26X 10EB4B38X 10GB4B18X 10HB4A99X 10IB4B28X 10JB4A93X 10KC4A09X 10AB4A09X 10BC4B96X 10CZ4B27X 10EB4B39X 10GB4B20X 10HB4B01X 10IB4B29X 10JB4A94X 10KC4A10X 10AB4A10X 10BC4B97X 10CZ4B28X 10EB4B40X 10GB4B21X 10HB4B02X 10IB4B30X 10JB4A95X 10KC4A11X 10AB4A11X 10BC4B98X 10CZ4B29X 10EB4B42X 10GB4B22X 10HB4B03X 10IB4B31X 10JB4A96X 10KC4A12X 10AB4A12X 10BC4B99X 10CZ4B30X 10EB4B43X 10GB4B23X 10HB4B04X 10IB4B32X 10JB4A97X 10KC4A13X 10AB4A13X 10BC4C01X 10CZ4B31X 10EB4B44X 10GB4B24X 10HB4B05X 10IB4B33X 10JB4A98X 10KC4A14X 10AB4A14X 10BC4C02X 10CZ4B32X 10EB4B45X 10GB4B25X 10HB4B06X 10IB4B34X 10JB4A99X 10KC4A15X 10AB4A15X 10BC4C03X 10CZ4B33X 10EB4B46X 10GB4B26X 10HB4B07X 10IB4B35X 10JB4B01X 10KC4A16X 10AB4A16X 10BC4C04X 10CZ4B34X 10EB4B47X 10GB4B28X 10HB4B08X 10IB4B36X 10JB4B02X 10KC4A17X 10AB4A17X 10BC4C05X 10CZ4B35X 10EB4B48X 10GB4B29X 10HB4B09X 10IB4B37X 10JB4B03X 10KC4A18X 10AB4A19X 10BC4C06X 10CZ4B36X 10EB4B50X 10GB4B30X 10HB4B10X 10IB4B38X 10JB4B04X 10KC4A19X 10AB4A20X 10BC4C07X 10CZ4B57X 10EC4A01X 10GB4B31X 10HB4B11X 10IB4B39X 10JB4B05X 10KC4A20X 10AB4A21X 10BC4C08X 10DA4A01X 10EC4A02X 10GB4B32X 10HB4B13X 10IB4B40X 10JB4B06X 10KC4A21X 10AB4A22X 10BC4C09X 10DA4A02X 10EC4A03X 10GB4B33X 10HB4B14X 10IB4B41X 10JB4B07X 10KC4A22X 10AB4A24X 10BC4C10X 10DA4A03X 10EC4A04X 10GB4B34X 10HB4B15X 10IB4B42X 10JB4B08X 10KC4A23X 10AB4A25X 10BC4C11X 10DA4A04X 10EC4A05X 10GB4B35X 10HB4B16X 10IB4B43X 10JB4B09X 10KC4A24X 10AB4A26X 10BC4C12X 10DA4A05X 10EC4A06X 10GB4B36X 10HB4B17X 10IB4B44X 10JB4B10X 10KC4A25X 10AB4A27X 10BC4C13X 10DA4A06X 10EC4A07X 10GB4B37X 10HB4B18X 10IB4B45X 10JB4B11X 10KC4A26X 10AB4A28X 10BC4C14X 10DA4A07X 10EC4A08X 10GB4B38X 10HB4B19X 10IB4B46X 10JB4B12X 10KC4A27X 10AB4A29X 10BC4C15X 10DA4A08X 10EC4A09X 10GB4B39X 10HB4B21X 10IB4B47X 10JB4B13X 10KC4A28X 10AB4A30X 10BC4C16X 10DA4A09X 10EC4A10X 10GB4B40X 10HB4B22X 10IB4B48X 10JB4B14X 10KC4A29X 10AB4A31X 10BC4C17X 10DA4A11X 10EC4A11X 10GB4B41X 10HB4B23X 10IB4B50X 10JB4B15X 10KC4A30X 10AB4A32X 10BC4C18X 10DA4A12X 10EC4A12X 10GB4B42X 10HB4B24X 10IB4B51X 10JB4B16X 10KC4A31X 10AB4A33X 10BC4C19X 10DA4A13X 10EC4A13X 10GB4B43X 10HB4B25X 10IB4B52X 10JB4B17X 10KC4A32X 10AB4A34X 10BC4C20X 10DA4A14X 10EC4A14X 10GB4B44X 10HB4B26X 10IB4B54X 10JB4B18X 10KC4A33X 10AB4A35X 10BC4C21X 10DA4A15X 10EC4A15X 10GB4B45X 10HB4B27X 10IB4B55X 10JB4B19X 10KC4A34X 10AB4A36X 10BC4C22X 10DA4A16X 10EC4A16X 10GB4B46X 10HB4B28X 10IB4B56X 10JB4B20X 10KC4A35X 10AB4A37X 10BC4C23X 10DA4A17X 10EC4A17X 10GB4B47X 10HB4B30X 10IB4B57X 10JB4B21X 10KC4A36X 10AB4A38X 10BC4C25X 10DA4A18X 10EC4A18X 10GB4B48X 10HB4B32X 10IB4B58X 10JB4B22X 10KC4A37X 10AB4A39X 10BC4C26X 10DA4A19X 10EC4A19X 10GB4B49X 10HB4B33X 10IB4B59X 10JB4B23X 10KC4A38X 10AB4A40X 10BC4C27X 10DA4A20X 10EC4A20X 10GB4B50X 10HB4B34X 10IB4B60X 10JB4B24X 10KC4A39X 10AB4A41X 10BC4C28X 10DA4A21X 10EC4A21X 10GC4A26X 10HB4B36X 10IB4B61X 10JB4B25X 10KC4A40X 10AB4A42X 10BC4C29X 10DA4A22X 10EC4A22X 10GC4A27X 10HB4B37X 10IB4B62X 10JB4B26X 10KC4A41X 10AB4A43X 10BC4C30X 10DA4A23X 10EC4A23X 10GC4A28X 10HB4B38X 10IB4B64X 10JB4B27X 10KC4A42X 10AB4A44X 10BC4C31X 10DA4A24X 10EC4A24X 10GC4A29X 10HB4B42X 10IB4B65X 10JB4B28X 10KC4A43X 10AB4A45X 10BC4C32X 10DA4A25X 10EC4A25X 10GC4A30X 10HB4B43X 10IB4B66X 10JB4B29X 10KC4A44X 10AB4A46X 10BC4C33X 10DA4A26X 10EC4A26X 10GC4A31X 10HB4B45X 10IB4B67X 10JB4B30X 10KC4A45X 10AB4A47X 10BC4C34X 10DA4A27X 10EC4A27X 10GC4A32X 10HB4B46X 10IB4B68X 10JB4B31X 10KC4A46X 10AB4A48X 10BC4C35X 10DA4A28X 10EC4A29X 10GC4A33X 10HB4B47X 10IB4B69X 10JB4B32X 10KC4A47X 10AB4A49X 10BC4C36X 10DA4A29X 10EC4A30X 10GC4A34X 10HB4B49X 10IB4B70X 10JB4B33X 10KC4A48X 10AB4A50X 10BC4C38X 10DA4A30X 10EC4A31X 10GC4A35X 10HB4B50X 10IB4B71X 10JB4B34X 10KC4A49X 10AB4A51X 10BC4C39X 10DA4A31X 10EC4A32X 10GC4A36X 10HB4B51X 10IB4B72X 10JB4B35X 10KC4A50X 10AB4A53X 10BC4C40X 10DA4A32X 10EC4A33X 10GC4A37X 10HB4B53X 10IB4B73X 10JB4B36X 10KC4A51X 10AB4A54X 10BC4C41X 10DA4A33X 10EC4A34X 10GC4A38X 10HB4B54X 10IB4B74X 10JB4B37X 10KC4A52X 10AB4A55X 10BC4C42X 10DA4A34X 10EC4A35X 10GC4A39X 10HB4B55X 10IB4B75X 10JB4B38X 10KC4A53X 10AB4A57X 10BC4C43X 10DA4A35X 10EC4A36X 10GC4A40X 10HB4B56X 10IB4B76X 10JB4B39X 10KC4A54X 10AB4A58X 10BC4C44X 10DA4A36X 10EC4A37X 10GC4A41X 10HB4B57X 10IB4B77X 10JB4B40X 10KC4A55X 10AB4A59X 10BC4C46X 10DA4A37X 10EC4A38X 10GC4A42X 10HB4B58X 10IB4B78X 10JB4B41X 10KC4A56X 10AB4A60X…
Recall started: March 21, 2019
Device type: Pump, Infusion, Implanted, Programmable
Root cause (FDA): Software change control
What the company told customers: On March 21, 2019, the firm issued Urgent Recall Notices to customers to inform them of the product issue. In May 2019, the firm sent updated communications to customers: Healthcare providers who have Clinician Programmers with SW 2.00.29 were sent a follow-up recall letter. This letter included the information that the pump stop following "Error Code 115" will only occur after the Bridge or Demand Bolus is complete, which could take up to seventy-two (72 hours). In addition, in the event of any cause of an "Error Code 115", the pump sounds a one-beep alarm and then shuts down. This behavior differs from the Instructions for Use, which state that the pump will sound three long (half second) beeps every 30 minutes for all critical errors. As it is unlikely that the patient will notice the single beep, there may be a significant delay in the patient becoming aware that the pump has stopped delivering therapy which may in turn delay resumption of drug therapy. Healthcare providers who have Clinician Programmers with any other version of the software and the implant pumps received a Corrective Action Notice. This notice included the information from the preceding paragraph, noting the discrepant alarm behavior for "Error Code 115" could be missed by the patient. Customers with the new Prometra Clinician Programmer software (v. 2.00.29) were asked to do the following: 1. STOP using the Periodic Flow or Multiple Rates flow mode functions in combination with a Bridge or Demand Bolus using the Clinician Programmer with Software Version 2.00.29. The error only occurs when these functions are used together. a. In the event that a Bridge or Demand Bolus is needed, convert the patient to Constant Flow Mode, then program the Bridge or Demand Bolus as needed (instructions for use PL-11803-04, page 30). Once the bolus is complete, revisit the patient or have him/her return to your clinic for programming back into their original flow mode. 2. IDENTIFY
Recall number: Z-1715-2019

Prometra II Programmable Pump (Clinical)…

Product: Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
Reason: The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
Quantity: 163
Codes and lots: Serial Numbers: 10ET4A02 36AR4A11 36AR4A33 36FR4A01 36HS4A25 36JN4A09 36JN4A30 36KN4A13 36KN4A33 10ET4A06 36AR4A12 36AR4A34 36FR4A08 36HS4A26 36JN4A10 36JN4A31 36KN4A15 36KN4A34 10ET4A07 36AR4A13 36AR4A35 36FR4A09 36HS4A27 36JN4A11 36JN4A32 36KN4A16 36KN4A35 10ET4A20 36AR4A14 36AR4A37 36FR4A12 36HS4A29 36JN4A12 36JN4A33 36KN4A17 36KN4A36 10ET4A21 36AR4A15 36BS4A08 36FR4A13 36HS4A34 36JN4A13 36JN4A35 36KN4A18 36KN4A38 10ET4A46 36AR4A16 36BS4A17 36FR4A16 36HS4A39 36JN4A14 36JN4A37 36KN4A19 36KN4A40 10IT4A16 36AR4A17 36BS4A18 36FR4A19 36HS4A42 36JN4A15 36JN4A39 36KN4A20 36KN4A41 10IT4A21 36AR4A18 36ES4A03 36FR4A22 36HS4A43 36JN4A16 36KN4A01 36KN4A21 36KN4A42 10IT4A22 36AR4A19 36ES4A07 36FR4A24 36HS4A46 36JN4A17 36KN4A02 36KN4A22 36KN4A43 36AR4A01 36AR4A20 36ES4A08 36HS4A01 36HS4A51 36JN4A18 36KN4A03 36KN4A23 36KN4A44 36AR4A02 36AR4A21 36ES4A14 36HS4A02 36HS4A53 36JN4A19 36KN4A04 36KN4A24 36KN4A45 36AR4A03 36AR4A22 36ES4A15 36HS4A04 36HS4A54 36JN4A21 36KN4A05 36KN4A25 36AR4A04 36AR4A23 36ES4A17 36HS4A07 36HS4A55 36JN4A22 36KN4A06 36KN4A26 36AR4A05 36AR4A24 36ES4A18 36HS4A10 36HS4A61 36JN4A23 36KN4A07 36KN4A27 36AR4A06 36AR4A27 36ES4A19 36HS4A14 36JN4A03 36JN4A25 36KN4A08 36KN4A28 36AR4A07 36AR4A29 36ES4A20 36HS4A20 36JN4A04 36JN4A26 36KN4A09 36KN4A29 36AR4A08 36AR4A30 36ES4A22 36HS4A21 36JN4A06 36JN4A27 36KN4A10 36KN4A30 36AR4A09 36AR4A31 36ES4A28 36HS4A22 36JN4A07 36JN4A28 36KN4A11 36KN4A31 36AR4A10 36AR4A32 36ES4A33 36HS4A23 36JN4A08 36JN4A29 36KN4A12 36KN4A32
Recall started: March 21, 2019
Device type: Pump, Infusion, Implanted, Programmable
Root cause (FDA): Software change control
What the company told customers: On March 21, 2019, the firm issued Urgent Recall Notices to customers to inform them of the product issue. In May 2019, the firm sent updated communications to customers: Healthcare providers who have Clinician Programmers with SW 2.00.29 were sent a follow-up recall letter. This letter included the information that the pump stop following "Error Code 115" will only occur after the Bridge or Demand Bolus is complete, which could take up to seventy-two (72 hours). In addition, in the event of any cause of an "Error Code 115", the pump sounds a one-beep alarm and then shuts down. This behavior differs from the Instructions for Use, which state that the pump will sound three long (half second) beeps every 30 minutes for all critical errors. As it is unlikely that the patient will notice the single beep, there may be a significant delay in the patient becoming aware that the pump has stopped delivering therapy which may in turn delay resumption of drug therapy. Healthcare providers who have Clinician Programmers with any other version of the software and the implant pumps received a Corrective Action Notice. This notice included the information from the preceding paragraph, noting the discrepant alarm behavior for "Error Code 115" could be missed by the patient. Customers with the new Prometra Clinician Programmer software (v. 2.00.29) were asked to do the following: 1. STOP using the Periodic Flow or Multiple Rates flow mode functions in combination with a Bridge or Demand Bolus using the Clinician Programmer with Software Version 2.00.29. The error only occurs when these functions are used together. a. In the event that a Bridge or Demand Bolus is needed, convert the patient to Constant Flow Mode, then program the Bridge or Demand Bolus as needed (instructions for use PL-11803-04, page 30). Once the bolus is complete, revisit the patient or have him/her return to your clinic for programming back into their original flow mode. 2. IDENTIFY
Recall number: Z-1716-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1712-2019, Z-1713-2019, Z-1714-2019, Z-1715-2019, Z-1716-2019. The agency record governs; check it and the company before acting.

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