BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, FMS2000

    MDR report key: 3750252 · Received January 28, 2014

    Report

    Report Number
    1219702-2014-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 24, 2014
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVAL. UPON RECEIPT, THE FAN GUARDS WERE VERY DIRTY AND THERE WAS A LOT OF BLOOD ON THE HOUSING, SUGGESTING THE UNIT WAS NOT CLEANED AFTER EACH USE AS STATED IN THE OPERATOR'S MANUAL. OTHERWISE, THE UNIT PERFORMED ACCORDING TO OUR SPECIFICATIONS. THE SYSTEM SHUT DOWN DUE TO OVER TEMPERATURE, AS IT IS DESIGNED TO DO: WHENEVER FLUID FROM THE HEAT EXCHANGER REACHES OUR SPECIFIED LIMIT, THE SYSTEM STOPS PUMPING AND HEATING, CLOSES OFF THE LINE TO THE PT AND INSTRUCTS THE USER TO RESTART THE SYSTEM WITH A NEW DISPOSABLE. THE VOLUME OF TUBING BETWEEN THE TEMPERATURE SENSOR AND THE PT IS 45 ML SO THAT NONE OF THE OVER TEMPERATURE FLUID CAN REACH THE PT. THE DISPOSABLE WAS DISCARDED BY THE USER AND THEREFORE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED BY THE BIOMED AT THE HOSPITAL, THAT THE BELMONT RAPID INFUSER, FMS2000, EXHIBITED AN "OVER TEMPERATURE" ERROR MESSAGE DURING A LIVER TRANSPLANT. THE SYSTEM WAS REPLACED AND THE CASE WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60243 THE BELMONT RAPID INFUSER, FMS2000 THERMAL INFUSION FLUID WARMER BSB BELMONT INSTRUMENT CORP. FMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK