BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUID MANAGEMENT SYSTEM

    MDR report key: 445941 · Received February 28, 2003

    Report

    Report Number
    1219702-2003-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2003
    Date of Event
    January 16, 2003
    Report Date
    February 22, 2003
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LIVER TRANSPLANT, SEVERAL BOLUES WERE USED, AND MAX RATE WAS ALSO USED. APP. 3 HRS INTO PROCEDURE, THE INJECTION PORT ABOVE THE RESERVOIR BECAME DISCONNECTED SPRAYING BLOOD PRODUCT AND CRYSTALLOID ON TO THE UNIT. THE UNIT WAS CLEANED AND LEAK WAS FIXED. NO PROBLEM WITH UNIT FOR THE NEXT 3 HRS. A TOTAL PUMPING TIME OF APP. 6 HRS AND 16,000 ML OF FLUIDS HAD BEEN INFUSED. SUDDENLY, THE UNIT EXHIBITED THE 'PUMP FAULT' ALARM AND STOPPED PUMPING. THE UNIT WAS TURNED OFF AND ON WITHOUT SUCCESS. A PUMP FROM OTHER MANUFACTURER REPLACED THE FMS2000 WITHOUT INCIDENT. THE ANESTHESIA TECHNICIAN FOUND A PIECE OF ROCKER (WITH PUMP ROLLER) LOOSENED AND FELL FROM THE PUMP HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUID MANAGEMENT SYSTEM INFUSION PUMP WITH WARMER FRN BELMONT INSTRUMENT CORP. FMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other