BEUDAMED
    FDA Adverse Event Other Summary report: N

    EM 2400 COMPOUNDER

    MDR report key: 866850 · Received June 13, 2007

    Report

    Report Number
    MW5002667
    Event Type
    Other
    Date Received
    June 13, 2007
    Date of Event
    June 5, 2007
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF A BAXA PUMP IN A MAIN PHARMACY IV ROOM. AN INACCURATE AMOUNT OF SOLUTION WAS PUMPED INTO NUMEROUS IV BAGS. DATES OF USE: 10 TPN'S AFFECTED; 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EM 2400 COMPOUNDER BAXA PUMP LHI BAXA CORPORATION 30164 34119

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other BAXA CORP AT LOCATION TO INSPECT PUMP ON 6/13/2007