BEUDAMED
    FDA Adverse Event Death Summary report: N

    L-70 HOTLINE 2 FLUID WARMING SET WITHOUT INJECTION PORT

    MDR report key: 1014053 · Received March 12, 2008

    Report

    Report Number
    1221261-2008-00004
    Event Type
    Death
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 12, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER DESCRIBES A POTENTIAL COMMUNICATION BETWEEN THE INNER LUMEN WITH THE OUTER LUMENS OF THE TUBING. THE USER NOTED THAT THE FLUID IN THE RESERVOIR TANK OF THE WARMER DECREASED DURING THE IV INFUSION TO THE PT. THEY STOPPED THE IV INFUSION AND TESTED THE PRODUCT BY CLOSING THE CLAMP OF THE FLUID BAG. THE USER NOTED THAT FLUID CONTINUED GOING OUT FROM THE PT END OF THE TUBING INFUSION SET.

    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. * 1192404

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death