BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUID WARMER

    MDR report key: 31314 · Received March 19, 1996

    Report

    Report Number
    MW1008664
    Event Type
    Malfunction
    Date Received
    March 19, 1996
    Date of Event
    February 16, 1996
    Report Date
    March 15, 1996
    Manufacturer
    LEVEL 1 TECHNOLOGIES, INC.
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE, THE BIOMED TECH WAS DRAWING THE FLUID IN WARMER TO REPLACE. THE FLUID WAS FULL OF BLOOD AND THE TECHNICIAN WAS EXPOSED TO THIS. RPTR DISINFECTED THE UNIT PER MFR'S RECOMMANDATIONS. THEY STATED TWO THINGS CAN CAUSE THIS 1) BAD O RINGS 2) A FAILURE OF THE DISPOSABLE CASSETTE. RPTR INSPECTED THE O RINGS AND ENSURED THESE ARE BEING LUBRICATED ON A MONTHLY BASIS. MFR STATED THIS IS NOT UNCOMMON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUID WARMER FLUID WARMER LHC LEVEL 1 TECHNOLOGIES, INC. H0250

    Patients

    Seq Age Sex Outcome Treatment
    1 *