BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELMONT FMS2000 FLUID MANAGEMENT SYSTEM

    MDR report key: 1861345 · Received October 4, 2010

    Report

    Report Number
    MW5017673
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    August 20, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING USE, BLOOD WARMER DISPOSABLE SET DEVELOPED A MAJOR LEAK NEAR THE HEATED RING SECTION. UNIT COULD NOT BE USED TO TRANSFUSE BLOOD. BLOOD WASTED. DELAY IN PROVIDING BLOOD TO PT. DISPOSABLE DEVELOPED A LEAK AT THE JUNCTION OF THE TOP OF THE HEATING RING AND THE CONNECTION FOR THE RED OUTFLOW TUBING. UNK IF THIS LEAK IS DUE TO A DEFECT IN THE SET OR DUE TO IMPROPER HANDLING OF THE SET. DEVICE INVOLVED DID NOT CONTRIBUTE TO THE FAILURE, BUT IS BEING TESTED FOR FUNCTIONAL SPECIFICATIONS. THE LEAKING SET WILL BE DISCUSSED WITH THE MANUFACTURER TO DETERMINE IF THEY NEED TO DO A FAILURE ANALYSIS. LEAKING SET WAS RETURNED TO THE MANUFACTURER (B)(4). IT SHOULD BE NOTED THAT DURING ROUTINE USE, THE AREA WHERE THIS LEAK HAPPENED IS NOT VISIBLE TO THE OPERATOR DUE TO THE PHYSICAL LOCATION OF THE WARMING RING ON THE SIDE OF THE DEVICE AWAY FROM THE OPERATOR. THE WARMING RING IS ALSO OBSCURED BY AN OPAQUE DOOR THAT COVERS THE RING. POSSIBLE LOTS ARE: 2010-08-03 LEA 2010-07-02 LLEA 2010-01-01 LEA 2009-09-04 LEA 2009-07-01 LEA. USED WITH FMS2000 WARMER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELMONT FMS2000 FLUID MANAGEMENT SYSTEM FLUID AND BLOOD WARMER BSB BELMONT INSTRUMENT CORPORATION FMS 2516 UNKNOWN, UP TO 5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other