BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2992637 · Received February 11, 2013

    Report

    Report Number
    2992637
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 11, 2013
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PUMP RATE FOR LIPIDS WAS CHECKED AT BEGINNING OF SHIFT TO BE RUNNING AT 0.9ML/HOUR. THROUGHOUT SHIFT LIPIDS CONTINUED TO RUN. IN THE MORNING, RN NOTICED THAT TUBING FOR LIPIDS WAS CLEAR ABOVE ALARIS PUMP. PAUSED FLUIDS AND CLAMPED LINE. OPENED PUMP TO FIND THAT TUBING WAS EMPTY UNTIL ABOUT HALFWAY POINT INSIDE THE ALARIS. NURSE NOTIFIED IMMEDIATELY AND STAT TRIGLYCERIDE LEVEL DRAWN. REMAINDER OF TUBING EMPTIED, HAD 16 MLS REMAINING OF LIPIDS. BAG STATED THAT BEGINNING INFUSION AMOUNT WAS 50MLS. PUMP INVESTIGATED AND SHOWED TO REPORT ONLY 17.41MLS INFUSED SINCE THE PREVIOUS AFTERNOON. IT IS UNKNOWN HOW MUCH LIPIDS WERE ACTUALLY INFUSED INTO PATIENT DUE TO MALFUNCTION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LIPID INFUSIONDEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60389 ALARIS PUMP, INFUSION FPA CAREFUSION 303, INC. 8100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY