BEUDAMED
    FDA Adverse Event Other Summary report: N

    "TINKER" BELMONT RAPID INFUSER

    MDR report key: 1998827 · Received February 17, 2011

    Report

    Report Number
    1219702-2011-00002
    Event Type
    Other
    Date Received
    February 17, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLICATED BELMONT RAPID INFUSER AND THE DISPOSABLE SET WERE NOT RETURNED FOR EVAL. THE SYSTEM HAD SHUT DOWN DUE TO OVER TEMP, AS IT IS DESIGNED TO DO: WHENEVER FLUID FROM THE HEAT EXCHANGER REACHES OUR SPECIFIED LIMIT, 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)(4), (B)(4) OF SALES AND MARKETING, (B)(4), AND REGIONAL SALES REP MET WITH THE LEAD ANESTHESIOLOGIST FOR LIVER TRANSPLANTS AT THIS HOSPITAL AFTER WE RECEIVED THE REPORT. THE LEAD ANESTHESIOLOGIST SPENT ABOUT 2 HOURS WITH US. AT THIS TIME, WE LEARNED THAT MAGNESIUM AND CALCIUM CHLORIDE WERE SOMETIMES ADDED INTO THE LARGE RESERVOIR CONTAINING BLOOD. FLUID CONTAINED WITHIN THE RESERVOIR IS PUMPED INTO THE DISPOSABLE SET HEAT EXCHANGER. THE LEAD ANESTHESIOLOGIST AGREED WITH US THAT ADDING MAGNESIUM OR CALCIUM TO THE RESERVOIR WOULD ESSENTIALLY REDUCE THE CITRATE EFFICACY AS AN ANTI-COAGULANT AND COULD RESULT IN CLOT FORMATION INSIDE THE HEAT EXCHANGER. THE ADDITION OF CALCIUM TO THE BLOOD BEING INFUSED IS CONTRAINDICATED WITH THE OPERATOR'S MANUAL AND LABELING PLACED ON THE MACHINE. FURTHERMORE, STANDARD TRANSFUSION PRACTICE CALLS FOR INFUSING CALCIUM THROUGH A SEPARATE INFUSION LINE (P.L. MOLLISON/C.P. ENGELFRIET, TRANSFUSION IN CLINICAL MEDICINE, 9TH ED., BLACKWELL SCIENTIFIC PUBLICATIONS, P. 701).

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: AFTER USING THE TINKER BELMONT FOR SEVEN HOURS DURING A LIVER TRANSPLANT SURGERY, THE DEVICE OVERHEATED. ALTHOUGH IT WAS TURNED OFF FOR APPROX 15 MINUTES AND SET UP AT A LOW RATE THE DEVICE CONTINUED ALARMING. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "TINKER" BELMONT RAPID INFUSER BLOOD WARMER BSB BELMONT INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other