BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CME BODYGUARD 323 AMBULATORY INFUSION PUMP

    MDR report key: 1410772 · Received July 7, 2009

    Report

    Report Number
    MW5011707
    Event Type
    Malfunction
    Date Received
    July 7, 2009
    Date of Event
    July 6, 2009
    Report Date
    July 7, 2009
    Manufacturer
    CME
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PUMP FAILED DURING INFUSION OF IVIG WHILE AT MAXIMUM RATE OF 165 ML/HR OF CARIMUNE 6% SOLUTION. PUMP READS MOTOR BREAK FAILURE AND ERROR 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CME BODYGUARD 323 AMBULATORY INFUSION PUMP CME BODYGUARD 323 AMBULATORY INFUSION PUMP FRN CME 323

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR