BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELMONT BUDDY FLUID WARMER

    MDR report key: 3868108 · Received May 29, 2014

    Report

    Report Number
    3868108
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 25, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING DELIVERY OF THE FOURTH UNIT OF PACKED CELLS, THE BELMONT ALARMED THAT IT WAS OVERHEATING AND BLOOD BEGAN TO LEAK FROM THE MACHINE. THE MACHINE WAS IMMEDIATELY TURNED OFF.EXAMINATION SHOWED THAT THE DISPOSABLE INSERT FOR THE MACHINE HAD MELTED, ALLOWING BLOOD TO LEAK FROM THE AFFECTED AREA.ADDITIONAL COMMENTS FROM A STAFF MEMBER PRESENT: THE BELMONT ALARMED AND STOPPED. I CHECKED THE PANEL DISPLAY AND IT SAID SOMETHING ABOUT "OVERHEATING" AND PERHAPS SOMETHING ABOUT THE CORE ELEMENT. I WAS PUZZLED, BUT IN THE NEXT 3 SECONDS, I NOTED THAT BLOOD HAD STARTED DRIPPING AND SPRAYING OUT OF THE UNIT ON THE BACK AND LOWER ASPECT OF THE MACHINE WERE THE TUBING EXITS. I OPENED THE DOOR AND BLOOD POURED OUT OF THE MACHINE'S INNARDS. I HAD A COLD AND SO CANNOT PERSONALLY VERIFY THE SMELL, BUT THE FELLOW I WAS WITH NOTED AN ACRID, BURNT ODOR EMANATING FROM THE TUBING OR DRIP CHAMBER. ON CLOSER INSPECTION, IT APPEARED THAT THE INNER DISC AT THE CENTER OF THE MACHINE (WHICH HOUSES THE HEATING ELEMENT WAS WARPED AND MELTED AND THAT THERE WAS A BREACH OR DISRUPTION OF THE TUBING ELEMENT SOON AFTER THIS POINT WHICH ALLOWED FOR THE BLOOD TO LEAK OUT OF THE 'CLOSED' SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317206 BELMONT BUDDY FLUID WARMER WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR NOT APPLICABLE.