BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELMONT BLOOD WARMER

    MDR report key: 2039338 · Received March 16, 2011

    Report

    Report Number
    2039338
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BELMONT INSTRUMENT CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AFTER 4 HOURS OF CONTINUOUS AND BOLUS USE OF THE BELMONT WARMER, THE OVERHEAT ALARM OCCURRED IMMEDIATELY AFTER REPERFUSION. THIS RESULTED IN HAVING TO CHANGE THE UNIT AND WASTE BLOOD PRODUCTS. THE PATIENT REQUIRED RESUSCITATION WITH PRESSORS FOR HYPOTENSION DUE TO HYPOVOLEMIA UNTIL THE NEW BELMONT WAS PRIMED AND LOADED. THE BELMONT REPRESENTATIVE WAS IMMEDIATELY AVAILABLE TO OBTAIN THE UNIT AND DISPOSABLES AND TO RUN TESTS ON BLOOD SAMPLES FROM THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELMONT BLOOD WARMER BLOOD WARMER FRN BELMONT INSTRUMENT CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *