BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CME BODYGUARD 323 INFUSION PUMP

    MDR report key: 2261476 · Received September 16, 2011

    Report

    Report Number
    MW5022322
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    September 12, 2011
    Report Date
    September 16, 2011
    Manufacturer
    CME AMERICA
    Product Code
    MEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CME BODYGUARD 323 INFUSION PUMP, DIALUDID CONCENTRATION: 10MG/ML 50ML VOLUME. PUMP PROGRAMMED AT A RATE OF 0.5MG/HR W/BOLUS DOSE OF 0.5MG G10MIN. AFTER 2 HR PUMP DELIVERED 2MG INSTEAD OF 1MG TOTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CME BODYGUARD 323 INFUSION PUMP INFUSION PUMP MEA CME AMERICA 323 61486

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening