BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "TINKER" BELMONT RAPID INFUSER

    MDR report key: 2002067 · Received January 28, 2011

    Report

    Report Number
    2002067
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE TINKER BELMONT FOR SEVEN HOURS DURING A LIVER TRANSPLANT SURGERY, THE DEVICE OVERHEATED. ALTHOUGH IT WAS TURNED OFF FOR APPROXIMATELY 15 MINUTES AND SET UP AT A LOW RATE, THE DEVICE CONTINUED ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "TINKER" BELMONT RAPID INFUSER BLOOD WARMER BSB BELMONT INSTRUMENT CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *