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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-1716-2019
Recall Event ID 82586
PMA Number P080012 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
Code Information 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
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 163
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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