BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH VOLUME IRRIGATION FLUID WARMER SYSTEM

    MDR report key: 29481 · Received January 25, 1996

    Report

    Report Number
    MW1008173
    Event Type
    Malfunction
    Date Received
    January 25, 1996
    Report Date
    January 18, 1996
    Manufacturer
    ALTON DEAN MEDICAL, INC.
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FOUR PROBLEMS WITH THE FLUID WARMER SYSTEM HAVE BEEN ENCOUNTERED IN THE ENDOUROLOGY SUITE DURING UROLOGICAL SURGICAL PROCEDURES: 1. WHEN THE WARMING CASSETTE IS INSERTED INTO THE UNIT, FLOW DECREASES TO AN UNACCEPTABLE LEVEL. 2. STOPCOCKS HAVE INTERMITTENTLY FALLEN OFF OF THE TUBING SETS. THIS COULD BE A RESULT OF BACK PRESSURE WHICH DEVELOPS AS A RESULT OF PROBLEM #1. 3. THE LUER-LOCK FITTINGS BETWEEN THE STERILE TUBING SETS AND THE NONSTERILE TUBING ARE OCCASIONALLY TOO TIGHT AND CANNOT BE SEPARATED. 4. FITTINGS ON THE TUBING SETS ARE OCCASIONALLY INCOMPATIBLE: MALE AND MALE OR FEMALE AND FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH VOLUME IRRIGATION FLUID WARMER SYSTEM FLUID WARMER SYSTEM LHC ALTON DEAN MEDICAL, INC. FW537, IF400

    Patients

    Seq Age Sex Outcome Treatment
    1 *