BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 19074290 · Received April 9, 2024

    Report

    Report Number
    3011581906-2024-00505
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    December 29, 2022
    Report Date
    April 9, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR WAS REVIEWED, AND THE PUMP PASSED ALL PREVIOUS TESTS. THERE IS ONE PREVIOUS COMPLAINTS ON THIS DEVICE. ANALYSIS OF THE RETURNED DEVICE WAS COMPLETED ON 4/8/2024: THE PUMP WAS POWERED ON AND THE PUMP WAS CONFIRMED TO HAVE THE LIBRARY "PLUS-V1". THE PUMP WAS SUPPOSED TO BE PROGRAMMED WITH THE LIBRARY "CHEMO V2", BUT THE LIBRARY WAS NEVER DOWNLOADED ONTO THE PUMP. THERE IS NO RECORD ON IQOS OF THE PUMP EVER BEING SENT THE CORRECT LIBRARY CONFIGURATION, AND NO RECORD OF THE CORRECT LIBRARY BEING DOWNLOADED. THE PUMP SHOULD NEVER HAVE BEEN SHIPPED TO THE CUSTOMER WITHOUT VERIFICATION THAT THE CORRECT LIBRARY WAS DOWNLOADED ONTO IT. FUNCTIONAL TESTING CONFIRMED THE REPORTED CONDITION AND WAS DUPLICATED DURING TESTING. REPORTED ISSUE FOUND, DEVICE NOT PERFORMING TO SPECIFICATION. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSES OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INFUTRONIX RECEIVED A REPORT FROM A HEALTHCARE FACILITY THAT AN INFUSION PUMP HAD THE INCORRECT LIBRARY LOADED. NO PATIENT WAS HARMED REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238173 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2206213120 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown