BEUDAMED
    FDA Adverse Event Other Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 2101843 · Received May 18, 2011

    Report

    Report Number
    1219702-2011-00011
    Event Type
    Other
    Date Received
    May 18, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLICATED BELMONT RAPID INFUSER AND THE DISPOSABLE SET WERE NOT RETURNED FOR EVAL. WE HAVE TESTED THE RAPID INFUSERS, FROM THIS HOSP, SEVERAL TIMES AND FOUND NO PROBLEMS. THE SYSTEM HAD SHUT DOWN DUE TO OVER TEMPERATURE, AS IT IS DESIGNED TO DO: WHENEVER FLUID FROM THE HEAT EXCHANGER REACHES 42 DEG C, AND THE SYSTEM STOPS PUMPING AND HEATING AND CLOSES OFF THE LINE TO THE PT. THE VOLUME OF TUBING BETWEEN THE TEMPERATURE SENSOR AND THE PT IS 45 ML SO THAT NONE OF THE OVER TEMPERATURE FLUID COULD HAVE REACHED THE PT. WE BELIEVE THAT CLOT FORMATION INSIDE THE HEAT EXCHANGER BLOCKING FLOW WAS THE MOST LIKELY CAUSE OF THE SYSTEM/HEAT EXCHANGER OVERHEATING RATHER THAN A SYSTEM MALFUNCTION. OUR COMPANY (B)(6), MET WITH THE LEAD ANESTHESIOLOGIST FOR LIVER TRANSPLANTS AT THIS HOSP AFTER WE RECEIVED THE REPORTS. WE ARE DILIGENTLY WORKING WITH THIS HOSP TRYING TO FIND THE ROOT CAUSE. OUR CLINICAL SPECIALIST AND THE ENGINEERING PROJECT MGR SPENT SEVERAL DAYS, OBSERVING VARIOUS OPERATIONS, ATTEMPTING TO FIND THE ROOT CAUSE. AT THIS TIME, WE ARE UNABLE TO FIND ANY PROBLEMS WITH OUR SYSTEM. (B)(4). THE COMPLAINT LISTED ABOVE IS NON-EXISTENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY UCLA THAT "AFTER APPROXIMATELY 3 HRS OF USE DURING AN ORTHOTOPIC LIVER TRANSPLANT (OLT), AFTER 21 UNITS OF FFP AND 9 UNITS OF PRBC, THE BELMONT UNIT ALARMED FOR OVERHEATING. THE UNIT WAS REMOVED FROM THE PT. A SAMPLE FROM THE DISTAL END OF THE INFUSION LINE WAS TESTED FOR CALCIUM AND THE RESULT WAS TOO LOW TO MEASURE. THE BELMONT WAS INFUSING THROUGHOUT THE ENTIRE CASE THROUGH A DEDICATED LEFT INTERNAL JUGULAR CORDIS. NO DRUGS OR ANY INJECTIONS WERE DELIVERED THROUGH THE LINE. THE BELMONT WAS PRIMED WITH 500 ML OF NORMAL SALINE (NS) ONLY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other