BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID INFUSER RI-2

    MDR report key: 17583897 · Received August 21, 2023

    Report

    Report Number
    17583897
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 13, 2023
    Report Date
    July 19, 2023
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRAUMA PATIENT IN EXTREMIS GETTING MASSIVE TRANSFUSION PROTOCOL. THE BLOOD PRODUCTS WERE INFUSING THROUGH A SUBCLAVIAN VEIN INTRODUCER WITHOUT DIFFICULTY AT 500 ML/MIN. AFTER 6 U WB, 5 RBC, AND 5 FFP, BELMONT DEVICE STATED THERE WAS A "SYSTEM ERROR 102 - INFUSATE OVER TEMPERATURE". 6 MONTH HISTORY OF SIMILAR EVENTS (AT LEAST 4); PER BELMONT INC. DIRECTION, TRY A DIFFERENT BELMONT DEVICE. EXISTING TUBING SWITCHED TO ANOTHER BELMONT AND WAS ABLE TO CONTINUE INFUSING WITHOUT DIFFICULTY. AFTER SEVERAL MINUTES AND SEVERAL MORE BLOOD PRODUCTS, STAFF BEGAN TO SMELL BURNT PLASTIC. BELMONT WAS INFUSING BUT AT THAT MOMENT, THEN SUDDENLY STOPPED, STATING ERROR 102. AT THIS POINT, NEW TUBING WAS PRIMED AND PLACED IN THE BELMONT JUST USED (APPROX. 3 MIN TO PRIME - PT. POST ARREST AND NOT GETTING BLOOD PRODUCTS). WITH THE NEW TUBING, BLOOD PRODUCTS WERE ABLE TO INFUSE WITHOUT DIFFICULTY AT 500 ML/HR. THE TUBING WAS EXTREMELY HOT, NOTING THAT THE HEATING COILS APPEARED TO BE BURNT. THE BURNT TUBING, PACKAGING, AND ORIGINAL BELMONT WERE SEQUESTERED BY CLINICAL ENGINEERING. MANUFACTURER RESPONSE FOR INFUSER, BELMONT (PER SITE REPORTER). REPORT SENT TO BELMONT 7/13/23. PREVIOUS NOTIFICATIONS HAVE YIELDED - SWITCH DEVICES TO A DIFFERENT BELMONT TRANSFUSION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483460 RAPID INFUSER RI-2 PUMP, INFUSION FRN BELMONT INSTRUMENT LLC 20230502

    Patients

    Seq Age Sex Outcome Treatment
    1 16060 DA Male