BEUDAMED
    FDA Adverse Event Death Summary report: N

    3-SPIKE DISPOSABLE SET (1 PIECE)

    MDR report key: 21710380 · Received March 27, 2025

    Report

    Report Number
    21710380
    Event Type
    Death
    Date Received
    March 27, 2025
    Date of Event
    March 24, 2025
    Report Date
    March 26, 2025
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DUE TO ACTIVE BLEEDING, A PATIENT WAS REQUIRING THE MASSIVE TRANSFUSION PROTOCOL. THE PATIENT WAS CRITICALLY ILL. THE STAFF SET-UP THE BELMONT RAPID INFUSER TO INFUSE THE BLOOD. AS THE BLOOD WAS INFUSING, THE STAFF NOTICED THE TUBING WAS LEAKING AND CAUSING THE BLOOD LEAK OUT. UPON EXAMINATION OF THE TUBING, THE STAFF NOTICED THE TUBING WAS CRACKED ABOVE THE BLUE ARROW. THE TUBING WAS REMOVED AND A 2ND SET OF TUBING WITH A DIFFERENT LOT NUMBER WAS UTILIZED. THE PATIENT DID NOT RECEIVE ALL THE BLOOD FROM THE UNIT TRANSFUSING. THE PATIENT DID HAVE A CARDIAC ARREST AND DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433204 3-SPIKE DISPOSABLE SET (1 PIECE) WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT LLC 903-00006P 20250115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death