BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS 8100

    MDR report key: 5356822 · Received January 11, 2016

    Report

    Report Number
    5356822
    Event Type
    Death
    Date Received
    January 11, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 22, 2015
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT ON A HEPARIN DRIP. RATE CHANGED AT 9AM TO 10.5ML/HR. NEW 250ML BAG HUNG AT 11:30AM WITH RATE CONTINUED AT 10.5ML/HR. AT 2:00PM, THE SAME DAY, THE BAG WAS EMPTY. SEVERAL HOURS LATER, THE PATIENT DEVELOPED RESPIRATORY DISTRESS AND REQUIRED TRANSFER TO CRITICAL CARE. HE DIED LESS THAN 24 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15923 ALARIS 8100 INFUSION PUMP FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death NO