BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMED GEMINI PC-2

    MDR report key: 1011397 · Received March 10, 2008

    Report

    Report Number
    MW5005850
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 10, 2008
    Manufacturer
    *
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMED GEMINI PC, MODEL #13250, WAS INFUSING FASTER THAN INTENDED RATE. PUMP WAS TURNED OFF AND FLUIDS CONTINUED TO INFUSE. PT RECEIVED A HIGHER RATE OF VOLUME AND HIGHER VOLUME THAN INTENDED. PT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMED GEMINI PC-2 IMED PUMP FRN * 13250 *

    Patients

    Seq Age Sex Outcome Treatment
    1