BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 17339682 · Received July 17, 2023

    Report

    Report Number
    3011581906-2023-00124
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 19, 2023
    Report Date
    October 19, 2023
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN OF THE DEVICE HAS BEEN REQUESTED. AS OF THE DATE OF THIS REPORT, DEVICE HAS NOT BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RETURNED DEVICE IS COMPLETE. THE RESULTS ARE BELOW: THE PUMP WAS CONNECTED TO AN ADMINISTRATION SET (HS-008, LOT # 2203016) AND AN 100 ML INFUSION WAS RUN. THE VOLUME INFUSED WAS 95.44 ML. THE PROGRAMMED VOLUME WAS 100 ML. SO, THE FLOW RATE DEVIATION IS -4.56%. THE FLOW RATE ACCURACY IS WITHIN +/- 5% WHICH MEETS THE PASSING CRITERIA. THE REPORTED ISSUE IS NOT CONFIRMED.

    Description of Event or Problem · 0

    A PUMP WAS NOT ADMINISTERING MEDICATION. PATIENT INVOLVEMENT IS UNKNOWN. VOLUME TO BE INFUSED AND MEDICATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145193 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2208092040 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown