BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE BELMONT RAPID INFUSER

    MDR report key: 10754926 · Received October 29, 2020

    Report

    Report Number
    10754926
    Event Type
    Death
    Date Received
    October 29, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 14, 2020
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CODE RED TRAUMA, MASS TRANSFUSION WAS ORDERED ON THE PATIENT. THE BELMONT RAPID INFUSER MALFUNCTIONED AND DID NOT INFUSE BLOOD AS NEEDED FOR THE PATIENT'S CARE EFFORTS. INSTEAD, THE BELMONT RAPID INFUSER WOULD ONLY ALARM HIGH PRESSURE AND STOP EVERY FEW SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221931 THE BELMONT RAPID INFUSER WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA Death