BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER, FMS2000

    MDR report key: 4197236 · Received October 2, 2014

    Report

    Report Number
    1219702-2014-00006
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    May 20, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BELMONT INSTRUMENT CORP.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED FOR EVALUATION; UPON RECEIPT, THE HOUSING WAS SEVERELY DAMAGED DUE TO AN IMPACT NOT REPORTED BY THE COMPLAINANT, AND THE DISPLAY WAS MISSING A LOT OF PIXELS. DUE TO THE STATE OF THE UNIT WE WERE UNABLE TO PERFORM AN INVESTIGATION AND THEREFORE UNABLE TO CONFIRM THE COMPLAINT. WE ATTEMPTED TO CONTACT THE CUSTOMER SEVERAL TIMES ABOUT THE REPAIR, BUT WERE UNSUCCESSFUL. AS WE WERE UNABLE TO CONFIRM THE COMPLAINT, AND THERE WAS NO INJURY TO THE PATIENT, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN RESPONSE TO MDR UF/IMPORTER REPORT NUMBER (B)(4): "THE PATIENT WAS HAVING ONGOING VAC OUTPUT AND IN SPITE OF ONGOING MASSIVE TRANSFUSION, CONTINUED DECREASE IN HIS HEMOGLOBIN. HE WAS MAKING GOOD URINE. HIS VAC OUTPUT WAS MODERATE BUT THERE WAS CONCERN FOR ABDOMINAL COMPARTMENT SYNDROME AND CONTINUE BLOOD LOSS. DOCTORS WERE UNABLE TO CORRECT HIS COAGULOPATHY (INABILITY FOR BLOOD TO CLOT). WE RETURNED TO THE OPERATING ROOM, EXPLORATION REVEALED CONTINUED OOZE FROM HIS RIGHT LOBE OF THE LIVER. THE PREPERITONEAL AREA WAS INSPECTED AS WAS HIS RIGHT GROIN AND THERE WAS NO HEMATOMA HERE. A LEFT CHEST TUBE WAS PLACED FOR CONCERN OF LEFT PNEUMOTHORAX DUE TO HIGH PEAK AIRWAY PRESSURE AND HYPOTENSION." BEFORE THE UNIT WAS RETURNED FOR EVALUATION, IT WAS REPORTED THAT THE BIOMED WAS UNABLE TO TEST THE UNIT DUE TO MISSING PIXELS ON THE DISPLAY. THE BIOMED REPORTED: "TRAUMA PT-BLOOD TUBING HOOKED UP UTILIZING THE BELMONT RAPID INFUSION. SEVERAL MINOR ERROR MESSAGES CAME UP THAT WERE ABLE TO BE RESOLVED BY ANESTHESIA TECH. AFTER ABOUT 10 MINS OF USE A LARGE ERROR MESSAGE APPEARED STATING THAT THE BLOOD TUBING AND ALL BLOOD PRODUCTS NEEDED TO BE CHANGED OUT. THE BELMONT WAS RESTARTED SEVERAL TIMES BUT DID NOT CLEAR ERROR MESSAGE. WE THEN PUSHED THE BELMONT OUT OF THE WAY AND HOOKED UP THE LEVEL ONE RAPID INFUSER. THE PROCEDURE THEN PROCEEDED WITH OUT ANY OTHER ISSUES WITH THE LEVEL ONE INFUSER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614317 THE BELMONT RAPID INFUSER, FMS2000 THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT CORP. FMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR