BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUID WARMER

    MDR report key: 34940 · Received August 2, 1996

    Report

    Report Number
    MW1009623
    Event Type
    Malfunction
    Date Received
    August 2, 1996
    Date of Event
    May 30, 1996
    Report Date
    May 31, 1996
    Manufacturer
    ALTON DEAN MEDICAL, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEAK IN DISPOSABLE TUBING WITH POSSIBLE CONTAMINATION OF THE PT LINE. ANESTHESIOLOGIST WAS USING A BLOOD PUMP ABOVE THE TUBING SET. HE WAS USING THE HAND PUMP TO DELIVER PUMP BLOOD TO THE PT WHEN THE TUBING SET IN THE FLUID WARMER STARTED TO LEAK BLOOD INTO AND OUT OF THE UNIT ONTO THE FLOOR. THE FLUID WARMING SET WAS TAKEN OUT OF THE PT'S IV LINE. ANOTHER FLUSHED WITH NORMAL SALINE AND RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUID WARMER INFUSION FLUID WARMER LGZ ALTON DEAN MEDICAL, INC. FW-537 G04HC401N

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY