BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 19362662 · Received May 21, 2024

    Report

    Report Number
    3011581906-2024-00580
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 21, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Removal / Correction Number
    Z-1285-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HISTORICAL TEST RECORDS WERE REVIEWED IN THE QOS SYSTEM. THE DEVICE HAD PASSED ALL TESTS. THERE WAS NO PREVIOUS COMPLAINT ON THIS DEVICE. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE PRODUCT INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE. A CAPA HAD BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSES OF THE REPORTED EVENTS AFTER THE EVALUATION. REFERENCE TO COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    ON 05/14/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD POWER ISSUE - DEVICE POWERS SELF OFF. PATIENT WOKE TO A POWERED OFF PUMP AND ONLY OPTION WAS NEW INFUSION. NO PATIENT WAS NOT HARMED. DEVICE WAS REQUESTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664880 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2208092040 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown