BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 7857273 · Received September 7, 2018

    Report

    Report Number
    1219702-2018-00029
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 8, 2018
    Report Date
    September 7, 2018
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    UDI-DI
    10896128002012
    PMA / PMN Number
    K032674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION BUT HAS NOT YET RESPONDED TO OUR REQUESTS. THE HARDWARE HAS NOT BEEN SERVICED BY BELMONT SINCE IT WAS MANUFACTURED IN 2013. WITHOUT FURTHER INFORMATION, IT IS DIFFICULT TO DETERMINE WHAT OCCURRED IN THIS INCIDENT. ONCE THE LOT NUMBER OF THE DISPOSABLE SET IS DETERMINED AND/OR THE PARTS ARE RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WITH ALL ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT FROM THE USER FACILITY STATED: "A LEVEL 1 TRAUMA WAS PERFORMED IN VOR 25. THE BELMONT WAS DEPLOYED AT APPROXIMATELY 0540. THE NIGHT TECH WAS RELIEVED BY A SENIOR DAY SHIFT ANESTHESIA TECH, AS OUR MASS TRANSFUSION PROTOCOL HAD BEEN ACTIVATED. AT APPROXIMATELY 0620, THE BELMONT HAD RESERVOIR HAD BEEN LOADED WITH RBC'S AND FFP AND PROGRAMMED TO RUN AT 500ML PER MINUTE. APPROXIMATELY 5-10 SECONDS LATER, IT WAS NOTED THAT BLOOD WAS SPEWING INSIDE THE UNIT. THE TECH OPENED THE DOOR AND NOTICED A LEAK AROUND THE CONNECTION OF THE RED ARROW THAT SITS RIGHT ABOUT THE HEATER RING. THE TECH WAS WISE ENOUGH TO PLUG THE LEAK WITH HER FINGER UNTIL A NEW DISPOSABLE COULD BE OBTAINED. ONCE THE TUBING WAS CHANGED OUT, THE TECH ATTEMPTED TO RUN THE BELMONT AT 500ML'S FLOW RATE. THE SCREEN INDICATED THAT THE RATE BEING ADMINISTERED WAS AT 500ML, BUT WAS ACTUALLY ONLY DELIVERING BETWEEN 187 AND 201 ML PER MINUTE. THE PRESSURE WAS FLUCTUATING BETWEEN 280 AND 305CC. DURING THIS TIME, THE BELMONT TUBING WAS CONNECTED TO A 14 GAUGE IV CATHETER. A MAC CENTRAL LINE WAS INSERTED, AND THE BELMONT WAS THEN CONNECTED TO ONE OF ITS PORTS. THE BELMONT PROCEEDED TO OPERATE WITHOUT INCIDENT THEREAFTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697344 THE BELMONT RAPID INFUSER THERMAL INFUSION FLUID WARMER LGZ BELMONT INSTRUMENT LLC FMS 2000 10896128002012

    Patients

    Seq Age Sex Outcome Treatment
    1