BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 3979037 · Received July 10, 2014

    Report

    Report Number
    3979037
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE HUNG 4G/100 ML BAG OF MAGNESIUM SULFATE. 34 MINUTES LATER SHE RETURNED TO HANG ANOTHER PIGGY BACK AND THE MAGNESIUM BAG WAS EMPTY. THE MODULE READ 25 ML/H BUT THE DRIP RATE IN THE DRIP CHAMBER WAS VERY FAST. SHE REVIEWED THE SET UP AND MODULE WAS PROGRAMMED CORRECTLY; 4 G TO INFUSE OVER 4 HRS AT 1 G/HR & 25 ML/H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405324 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8015 *
    405325 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR