BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS

    MDR report key: 17437478 · Received July 31, 2023

    Report

    Report Number
    MW5120452
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 27, 2023
    Manufacturer
    INFUTRONIX LLC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NIMBUS INFUSION PUMP. NIMBUS II PUMP. MANUFACTURED IN CHINA FOR INFUTRONIX LLC. PUMP ABRUPTLY POWERS OFF ON IT'S OWN WITHOUT WARNING CAUSING THE SETTINGS TO BE WIPED OUT. THE HOME INFUSION STOPS INFUSING AND CANNOT RESUME WITHOUT COMING BACK INTO THE CLINIC TO HAVE A NEW PUMP PLACED CAUSING A DELAY IN TREATMENT. BATTERY POWER WAS FULL. BATTERY IS A FANSO ER18505M 3.6V LITHIUM BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469971 NIMBUS II PLUS PUMP, INFUSION FRN INFUTRONIX LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other FLUOROURACIL.