BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 6204955 · Received December 27, 2016

    Report

    Report Number
    6204955
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 25, 2016
    Report Date
    December 1, 2016
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD HEPARIN GTT INFUSING WITH THE FULL BAG HUNG. RN SET THE INFUSION RATE AT 18CC/HR AND LOCKED THE PUMP. TWENTY MINUTES LATER THE RN NOTICED THE HEPARIN BAG HALF EMPTIED AND PUMP WAS DRIPPING KVO (KEEP VEIN OPEN) AND FASTER THAN PUMP WAS SET. LAB TESTING CONFIRMED EVALUATED PTT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854591 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR