BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS J AMBULATORY INFUSION PUMP

    MDR report key: 18211706 · Received November 27, 2023

    Report

    Report Number
    3011581906-2023-00735
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    December 27, 2022
    Report Date
    November 27, 2023
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THIS PUMP PASSED ALL PREVIOUS TESTS. COMPLIANT DATA WAS REVIEWED; THERE ARE NO PREVIOUS COMPLIANTS ON THIS DEVICE. UPON REVIEWING THE EVENT LOG, UPSTREAM OCCLUSIONS IN COMBINATION WITH AN ABRUPT POWER OFF WERE CONFIRMED. THE ABRUPT POWER OFF EVENT OCCURRED ALMOST IMMEDIATELY AFTER THE UPSTREAM OCCLUSION WAS PRESENT. 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 INVESTIGATIONS ASSOCIATED WITH CAPA IT2023-15 FOR POWER ISSUES AND CAPA IT2021-13 FOR UPSTREAM OCCLUSIONS.

    Description of Event or Problem · 0

    ON 12/28/2022, 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
    222868 NIMBUS J AMBULATORY INFUSION PUMP AMBUALTORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS J 210219720 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown