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U.S. Department of Health and Human Services

Class 2 Device Recall Prometra Programmable Infusion Pump System, Prometra Clinician Programmer

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  Class 2 Device Recall Prometra Programmable Infusion Pump System, 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-1712-2019
Recall Event ID 82586
PMA Number P080012 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Code Information 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
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 318
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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