BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD

    MDR report key: 8565329 · Received April 29, 2019

    Report

    Report Number
    MW5086274
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    March 12, 2019
    Report Date
    April 3, 2019
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BODYGUARD 323 PUMP WAS GIVING "MISSING KEY" ERROR CODE. CALLED MFR AND THEY SAID THE PUMP MUST BE SENT OFF FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356502 BODYGUARD PUMP, INFUSION FRN CME AMERICA, LLC 323

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR