BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMED GEMINI PCA

    MDR report key: 18848 · Received November 29, 1994

    Report

    Report Number
    18848
    Event Type
    Injury
    Date Received
    November 29, 1994
    Date of Event
    November 28, 1994
    Report Date
    November 29, 1994
    Manufacturer
    IMED CORP.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PUMP ALARMED, THEN SENT MESSAGE "HELP, HELP, HELP" THE "TAKE LINES OUT OF CHANNEL" "INTERNAL FAILURE". IV FLUIDS BEGAN FREE FLOWING INTO PT. DURING ALARM, LEVOPHED IN LT ARTIUM, DOPAMINE AND HEPARIN IN CENTRAL LINE. PT'S BP WENT UP TO 240/130, HR 130.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMED GEMINI PCA INFUSION PUMP FRN IMED CORP. PC4

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening PB VENTILATOR, BIVAD