BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, FMS2000

    MDR report key: 3847000 · Received March 14, 2014

    Report

    Report Number
    1219702-2014-00003
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 13, 2014
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REMOVED FOR EVAL. WE WERE UNABLE TO DUPLICATE THE COMPLAINT UPON RECEIPT; THE UNIT PERFORMED ACCORDING TO OUR SPECS. THE BIOMED REPORTED THAT 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 OVERTEMPT" ALARM DUE TO BLOCKED FAN AIR VENTS CAUSING THE POWER DRIVER MODULE TO OVERHEAT, OR AN "OVER TEMPERATURE" ALARM DUE TO OVER TEMPERATURE FLUID SUPPLY 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 EFFECTIVE INFUSING, IT STOPS PUMPING AND HEATING, STOPS INFUSING FLUID INTO THE PT, DISPLAYS AN ALARM MESSAGE, INSTRUCTIONS FOR CORRECTIVE MEASURE, AND SOUNDS AN AUDIBLE ALARM.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED BY A BIOMED AT THE HOSPITAL, THAT THE BELMONT RAPID INFUSER, FMS2000, EXPERIENCED AN OVERHEAT INCIDENT DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152384 THE BELMONT RAPID INFUSER, FMS2000 THERMAL, INFUSION FLUID WARMER, 80 LGZ BSB BELMONT INSTRUMENT CORP. FMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK