BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-70 HOTLINE 2 FLUID WARMING SET WITHOUT INJECTION PORT

    MDR report key: 1103147 · Received May 27, 2008

    Report

    Report Number
    1221261-2008-00020
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES A LEVEL 1 HOTLINE HL-90 BLOOD, AND IV FLUID WARMING DEVICE AUDIBLY ALARMED. THE WATER LEVEL IN THE DEVICE'S HEATED WATER-BATH RESERVOIR WAS NOTED TO BE BELOW THE MINIMUM LEVEL MARKER. BLOOD APPEARED TO BE PRESENT IN THE RESERVOIR. AN INTERMITTENT BACK-FLOW OF BLOOD FROM THE PT TO THE DEVICE WAS ALSO OBSERVED. NO ADVERSE OUTCOME 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. * 1282168

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR