BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS - IMED GEMINI PC-4

    MDR report key: 479783 · Received July 28, 2003

    Report

    Report Number
    479783
    Event Type
    Death
    Date Received
    July 28, 2003
    Date of Event
    July 13, 2003
    Report Date
    July 24, 2003
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED DOPAMINE AND EPINEPHRINE DRIPS I.V. NURSE HUNG NEW BAG OF EPINEPHRINE, TRIED TO CHANGE RATE ON I.V. PUMP AND PUMP MADE "SHRILL" ALARM, SAID "MALFUNCTION" ON SCREEN AND SHUT DOWN/OFF. PT WENT ASYSTOLE. PT WAS RESUSCITATED, BUT CODED ABOUT 1 HOUR LATER AND DIED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/6/03: THE EVENTS LEADING UP TO THE MALFUNCTION HAD BEEN OVERWRITTEN IN THE LOG DUE TO THE SUSEQUENT TESTING OF THE DEVICE BY THE CUSTOMER. TESTING AND INSPECTION COULD NOT DUPLICATE THE EVENT AND FOUND NO ISSUES WITH THE DEVICE. THIS DEVICE STILL HAD 1.85 VERSION SOFTWARE, AND WAS NEVER UPGRADED ACCORDUING TO THE RECOMMENDATION IN SERVICE BULLETIN #466 FROM DECEMBER 1999. IT IS POSSIBLE THAT THE 839 ERROR COULD HAVE BEEN AVOIDED WITH THE CURRENT SOFTWARE VERSION. STANDARD SERVICE INCLUDING SOFTWARE UPGRADE TO VERSION 1.93 WAS PERFORMED PRIOR TO RETURNING UNIT TO CUSTOMER. THE FREQUENCY OF THIS ERROR IS VERY LOW WITH NO APPARENT UPWARD TREND. NO INFO HAS BEEN PROVIDED TO ALARIS MEDICAL SYSTEMS, INC, REGARDING CAUSES OF DEATH OR AUTOPSY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS - IMED GEMINI PC-4 VOLUMETRIC INFUSION PUMP / CONTROLLER FRN ALARIS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death