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U.S. Department of Health and Human Services

Class 2 Device Recall Prometra Programmable Pump System

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  Class 2 Device Recall Prometra Programmable Pump System see related information
Date Initiated by Firm March 21, 2019
Create Date June 03, 2019
Recall Status1 Terminated 3 on June 05, 2020
Recall Number Z-1714-2019
Recall Event ID 82586
PMA Number P080012 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Code Information 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 1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Recalling Firm/
Manufacturer
Flowonix Medical Inc
120 Forbes Blvd Ste 170
Mansfield MA 02048-1150
For Additional Information Contact Technical Solutions Department
855-356-9665
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software change control
Action 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
Quantity in Commerce 809
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = FLOWONIX MEDICAL, INC.
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