BEUDAMED
    FDA Recall Open, Classified

    Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228

    Recall: Z-1121-2020 · Initiated December 24, 2019

    Recall

    Recall Number
    Z-1121-2020
    Event Number
    84653
    Firm
    Flowonix Medical Inc
    FEI Number
    3010079947
    Product Code
    LKK
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    December 24, 2019
    Posted
    February 10, 2020
    Address
    120 Forbes Blvd, Ste 170, Mansfield, MA, 02048-1150

    Description

    Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228

    Reason

    A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

    Action

    ***Updated 5/12/2023*** On May 11, 2023, the firm sent an URGENT MEDICAL DEVICE CORRECTION UPDATE letter to all affected customers, which informed them of an update to Flowonix's plan to correct the firmware issue. Flowonix will NOT be conducting an office-based pump firmware update for affected pumps implanted prior to January 2020. Healthcare providers were provided ongoing recommendations for Prometra and Prometra II pumps implanted prior to January 2020, which are impacted by this issue. Healthcare providers should contact their Flowonix Representative or our Technical Solutions Department (1-855-356-9665) in the event cessation of therapy or premature low battery is suspected and/or have general questions regarding this notice. *** On December 24, 2019, the firm notified affected users via an Urgent Medical Device Corrective Action Recall Notice. The firm advised customers of the product issue and reminded customers that the pumps are currently labeled only for use with Infumorph. Due to the low risk that this failure mode may occur, Flowonix is not recommending that pumps be explanted. Healthcare providers were recommended to inform patients regarding the symptoms and adverse health events associated with an unexpected pump stoppage and the appropriate steps to take in the event they suspect a stoppage. The firm will be implementing a correction of firmware errors to bring the pumps back into specification. The firm will follow up when the change has been completed. An office-based pump firmware update is being developed for patients currently implanted with the affected pumps. (Note, as of the 5/12/23 update, implanted pumps will not be receiving a firmware update.)

    Distribution

    Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

    Quantity

    6670 (US)