BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-SPIKE DISPOSABLE SET

    MDR report key: 10493689 · Received September 4, 2020

    Report

    Report Number
    10493689
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    July 27, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HAD MTP INFUSION IN TRAUMA ROOM ON TRAUMATIC HYPOTENSIVE PATIENT USING BELMONT INFUSER. WHILE PACKAGING PATIENT TO GO TO THE OR, BLOOD WAS INFUSED USING 500 ML PRESSURE BAG BY REMOVING RAPID INFUSER BLOOD TUBING FROM THE BELMONT MACHINE AS THE BELMONT MACHINE WAS UNPLUGGED FOR TRANSPORT TO OR. EN-ROUTE TO OR, BELMONT TUBING CONNECTION PULLED APART RESULTING IN LOSS OF APPROXIMATELY 100 ML WHOLE BLOOD. AFTER INCIDENT AND BRIEFING, NEW BELMONT BLOOD TUBING WAS OPENED IN NEW PACKAGING AND CONNECTION FOUND TO BE LOOSE UPON OPENING PACKAGE. EDUCATOR MADE AWARE OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957215 3-SPIKE DISPOSABLE SET WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT CORPORATION 2020-05 03

    Patients

    Seq Age Sex Outcome Treatment
    1 7300 DA