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U.S. Department of Health and Human Services

Class 2 Device Recall Prometra Clinician Programmer

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  Class 2 Device Recall Prometra Clinician Programmer 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-1713-2019
Recall Event ID 82586
PMA Number P080012 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Code Information 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
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.
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 40
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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