BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMARTSITE

    MDR report key: 3021289 · Received March 20, 2013

    Report

    Report Number
    3021289
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    UPON ENTERING ROOM, IV INFUSION PUMP CONTAINING FAT EMULSION WAS ALARMING AIR IN LINE. NURSE OPENED INFUSION PUMP CHAMBER TO INSPECT TUBING. UPON OPENING CHAMBER IV TUBING DISCONNECTED FROM ABOVE THE CLAMP SITE IN THE CHAMBER, LEAVING THE TUBING IN TWO PIECES AND DRIPPING LIPIDS ALL OVER PATIENTS FLOOR. NURSE IMMEDIATELY TURNED OFF CHAMBER AND DISCONNECTED FAT EMULSION FROM PATIENT. FAULTY IV TUBING PLACED IN BIOHAZARD BAG AND GIVEN TO THE CLINICAL LEADER ON SHIFT. PHARMACY CALLED TO SEND UP REPLACEMENT LIPIDS AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LIPID INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116180 ALARIS SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR