BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PC UNIT

    MDR report key: 6134423 · Received November 30, 2016

    Report

    Report Number
    6134423
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 28, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ON LEVOPHED @ 0.2 MCG/KG/MIN. WITHOUT WARNING, THE ALARIS IV PUMP TURNED OFF AND DISPLAYED A RED WARNING MESSAGE ABOUT AN ERROR ON THE CENTRAL PUMP BRAIN. THE LEVOPHED WAS INFUSING IN A CHANNEL TO THE RIGHT OF THE BRAIN WHICH HAD A SINGLE CHANNEL. THERE WERE TWO OTHER CHANNELS/MEDICATIONS INFUSING TO THE LEFT OF THE BRAIN WHICH WERE REPORTEDLY UNAFFECTED. THE PATIENT'S MEAN ARTERIAL PRESSURE DROPPED INTO THE 50'S. THE NURSE WAS ABLE TO TOUCH A BUTTON ON THE PUMP (DOESN'T RECALL WHICH BUTTON) AND THE INFUSION STARTED UP AGAIN WITHOUT THE NURSE DISCONNECTING ANY CHANNELS. REPORTEDLY, THE BLOOD PRESSURE IMPROVED AFTER RESTARTING THE LEVOPHED BUT AT SOME POINT SHORTLY AFTER THAT, THE PATIENT SUFFERED A CARDIAC ARREST AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785785 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION 303, INC. 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death CARDIAC DRUGS| DIALYSIS| NO