BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD

    MDR report key: 2680261 · Received June 28, 2012

    Report

    Report Number
    3006967710-2012-00001
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Report Date
    May 29, 2012
    Manufacturer
    CME AMERICA LLC
    Product Code
    FPA
    PMA / PMN Number
    K042696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT OF THE EVAL AND RESULTS WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE INSPECTION AT THE BIOMEDICAL FACILITY, THE BODYGUARD 323 INFUSION PUMP INFUSION RATE INCREASED TO THE PRIMING RATE (1200 MLS PER HOUR) FOR A FEW SECONDS BEFORE STOPPING AND ALARMING. THE PUMP WAS NOT IN USE ON A PT AND WAS IMMEDIATELY REMOVED FROM SERVICE AND RETURNED TO THE MFR FOR SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODYGUARD FRN - INFUSION PUMP FPA CME AMERICA LLC BG 323

    Patients

    Seq Age Sex Outcome Treatment
    1