BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELMONT FMS2000 FLUID MANAGEMENT SYSTEM

    MDR report key: 1861346 · Received October 4, 2010

    Report

    Report Number
    MW5017674
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FMS TUBING LEAKED BLOOD INTO MACHINE. UNIT COULD NOT BE USED TO TRANSFUSE BLOOD. BLOOD WASTED. DELAY IN PROVIDING BLOOD TO PT. DR. (B)(6) CALLED CLINICAL ENGINEERING DEPT AND WILL SAVE TUBING AND TURN INTO DEPT ON MONDAY FOR INVESTIGATION. THIS IS THE SECOND DISPOSABLE FAILURE SEEN IN THE PAST 5 WEEKS. DISPOSABLE DEVELOPED A LEAK AT THE TOP SURFACE OF THE WARMING RING -AS INSTALLED IN THE DEVICE- AT THE 2 O'CLOCK POSITION. DISPOSABLE WILL BE SENT BACK TO THE MANUFACTURER FOR ANALYSIS. THE LEAK APPEARED TO BE AT THE JUNCTION OF THE TOP SURFACE AND SIDE SURFACE OF THE WARMING RING -AT THE SEAM-. DISPOSABLE RETURNED TO VENDOR FOR FAILURE ANALYSIS (B)(4). LOTS OF THIS DISPOSABLE WE HAVE ON SITE INCLUDE: 2010-08-03 LEA, 2010-07-02 LLEA, 2010-01-01 LEA, 2009-09-04 LEA, 2009-07-01 LEA. DISPOSABLE USED ON DEVICE FMS 2000 (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other