BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, FMS2000

    MDR report key: 3941629 · Received April 15, 2014

    Report

    Report Number
    1219702-2014-00004
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. WE WERE UNABLE TO DUPLICATE THE COMPLAINT UPON RECEIPT; THE UNIT PERFORMED ACCORDING TO OUR SPECIFICATIONS. THE DISPOSABLE SET WAS NOT RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THAT THE ERROR MESSAGE ON THE SCREEN WAS "OVERHEATING". HOWEVER, THE SYSTEM DOES NOT HAVE AN "OVERHEATING" ALARM. THE UNIT MOST LIKELY EXHIBITED EITHER A "POWER MODULE OVERTEMP" ALARM DUE TO BLOCKED FAN AIR VENTS CAUSING THE POWER DRIVER MODULE TO OVERHEAT, OR AN "OVER TEMPERATURE" ALARM DUE TO OVERHEATED INFUSATE, POSSIBLY CAUSED BY DIRTY TEMPERATURE PROBES OR AN OCCLUDED FLOW PATH. BOTH ALARMS WILL CAUSE THE SYSTEM TO SHUT DOWN, AS IT IS DESIGNED TO DO. WHEN THE FMS2000 RECOGNIZES A SITUATION THAT IS COMPROMISING EFFECT INFUSING, IT STOPS PUMPING AND HEATING, STOPS INFUSING FLUID INTO THE PATIENT, DISPLAYS AN ALARM MESSAGE, INSTRUCTIONS FOR CORRECTIVE MEASURE, AND SOUNDS AN AUDIBLE ALARM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DOCTOR AT (B)(6) THAT DURING A PROCEDURE, THE BELMONT ALARMED AND STOPPED, DISPLAYING AND "OVERHEATING" MESSAGE. A LEAK WAS THEN NOTICED, AND WHEN THE DOOR WAS OPENED THEY FOUND THAT THE DISPOSABLE WAS WARPED AND MELTED. THE MACHINE WAS REPLACED WITH ANOTHER BELMONT AND THE CASE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230290 THE BELMONT RAPID INFUSER, FMS2000 THERMAL INFUSION FLUID WARMER 80 LGZ LGZ BELMONT INSTRUMENT CORPORATION FMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK