BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II FLEX AMBULATORY INFUSION PUMP

    MDR report key: 18210447 · Received November 27, 2023

    Report

    Report Number
    3011581906-2023-00732
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    March 22, 2023
    Report Date
    November 27, 2023
    Manufacturer
    INFUTROINX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020093
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THE PUMP PASSED ALL PREVIOUS TESTS, COMPLIANT DATA WAS REVIEWED; THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. THE EVENT LOG FOR NIMBUS II FLEX, SERIAL NUMBER (B)(6) WAS REVIEWED, AND IT WAS CONFIRMED THAT THE PUMP HAD AN ABRUPT POWERED-OFF EVENT DURING THE PATIENT'S INFUSION. THE PERFORMANCE TEST WAS CONDUCTED ON THE NIMBUS II FLEX, SERIAL NUMBER (B)(6), WHERE THE PUMP POWERED OFF WITH AN OLD BATTERY, BUT THE PUMP COMPLETED THE INFUSION WITH A NEW BATTERY. THE REPORTED COMPLAINT ISSUE WAS CONFIRMED IN THE EVENT LOG, AND THOUGH IT WAS REPEATED IN THE PERFORMANCE TEST IT WAS CLEAR THAT THE ISSUE WAS WITH THE BATTERY. THE PUMP WAS FOUND TO BE OPERATING OUTSIDE THE SPECIFICATION AND DOES NOT MEET THE ACCEPTANCE CRITERIA. THIS COMPLAINT HAS BEEN REVIEWED AND EVALUATED AS PART OF THE PROTOCOL FOR COMPLAINT CLOSURE FOR INFUTRONIX LLC AND ZYNO MEDICAL LLC (PROTOCOL#6) AND DETERMINED TO BE INCLUDED IN THE INVESTIGATION ASSOCIATED WITH CAPA IT2023-15.

    Description of Event or Problem · 0

    ON (B)(6) 2023, INFUTRONIX RECEIVED A REPORT THAT A PUMP POWERED OFF ON ITS OWN WITHOUT WARNING, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239448 NIMBUS II FLEX AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTROINX, LLC NIMBUS II FLEX 190527480 00817170020093

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown