BEUDAMED
    FDA Adverse Event Other Summary report: N

    L-70 NORMOTHERMIC FLUID WARMING SET

    MDR report key: 272318 · Received March 28, 2000

    Report

    Report Number
    1221261-2000-00001
    Event Type
    Other
    Date Received
    March 28, 2000
    Date of Event
    February 21, 2000
    Report Date
    March 20, 2000
    Manufacturer
    SIMS LEVEL 1, INC.
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SIMS LEVEL 1 RECEIVED A REPORT FROM SIMS CANADA, LTD THAT ABOUT HALF HOUR-HOUR INTO A SURGICAL PROCEDURE, AN ANETHESIA PHYSICIAN NOTICED THAT THE DRIP CHAMBER OF THE Y SET WAS COMPLETELY FILLED WITH FLUID AND PT WAS IN PRONE POSITION AND THE ARM WAS BENDING FROM TOO MUCH FLUID BEING INFUSED AT A FAST RATE. THE PHYSICIAN THEN DETERMINED THAT THE FLUID FROM THE WATER RESEVOIR HAD CROSSED OVER INTO THE IV PATH. THE DISPOSABLE SET WAS RETURNED TO LEVEL 1 AND UPON VISUAL EXAMINATION, IT WAS NOTED THAT THERE WAS A NEEDLE-STICK PUNCTURE IN THE TOP IF THE Y-INJECTION PORT. UPON DESTRUCTIVE TESTING AND VISUALIZATION UNDER A MICROSCOPE, IT WAS NOTED THAT THERE WAS A PUNCTURE FROM A NEEDLE, THROUGH THE CONNECTOR WALL AND INTO THE IV PATH OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-70 NORMOTHERMIC FLUID WARMING SET IV AND BLOOD ADMINSTRATION SET LGZ SIMS LEVEL 1, INC. L-70 199811A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other