BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-70 HOTLINE 2 FLUID WARMING SET WITHOUT INJECTION PORT

    MDR report key: 1113843 · Received May 23, 2008

    Report

    Report Number
    1221261-2008-00018
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 25, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THEY HAD BEEN INFUSING CRYSTALLOIDS AND BLOOD TO PT DURING SURGERY. THEY HAD KIND OF EMERGENCY SITUATION AND PLACED FIRST CRYSTALLOID BAG INTO PRESSURE INFUSOR. AFTER A WHILE, THEY NOTICED BUBBLES. BUBBLES WERE ON THE END OF SET WHICH CONNECT TO HOTLINE. SHORTLY, THEY NOTICED THAT WATER IS DRIPPING TO THE FLOOR AND SAW THE WATER CHAMBER OF WARMER WAS FILLED UP. THEY CHANGED CRYSTALLOID BAG TO BLOOD BAG AND WATER CHAMBER COLORED RED. THEY STOPPED IMMEDIATELY USING HOTLINE AND TOOK STRAIGHT TUBING AND BYPASSED WARMER. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-70 HOTLINE 2 FLUID WARMING SET WITHOUT INJECTION PORT E157735 INTRAVENOUS ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. * 1174785

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR