BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID INFUSER

    MDR report key: 2039392 · Received March 16, 2011

    Report

    Report Number
    2039392
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BELMONT INSTRUMENT CORP
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SET UP THERMOCOR FOR BLOOD TRANSFUSION. BEFORE INITIATED USE, FOUND BLOOD LEAKING FROM THE BOTTOM OF DISPOSABLE. SWITCHED TO BELMONT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID INFUSER BLOOD TRANSFUSION FRN BELMONT INSTRUMENT CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *