BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARD 323

    MDR report key: 7978822 · Received October 17, 2018

    Report

    Report Number
    MW5080636
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    September 28, 2018
    Report Date
    October 16, 2018
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS USING A BODYGUARD PUMP TO ADMINISTER INOTROPIC THERAPY. DURING USE, THE PUMP ALARMED FOR "LOW BATTERY". PATIENT REVIEWED PUMP BATTERY LEVEL, PUMP APPEARED TO BE APPROPRIATELY CHARGED, PATIENT CONTINUED ITS USE, PUMP FAILED AND CEASED ADMINISTERING MEDICATION. PATIENT DID NOT NOTICE CEASED OPERATION FOR APPROXIMATELY EIGHT HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817182 BODYGUARD 323 PUMP, INFUSION FRN CME AMERICA, LLC BODYGUARD 323 122909

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention