BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID INFUSER

    MDR report key: 2039404 · Received March 21, 2011

    Report

    Report Number
    2039404
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 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

    BELMONT OVERHEATED AFTER TRANSFUSING ABOUT 8 OR 9 UNITS RED BLOOD CELLS (RBC) AND 7 OR 8 UNITS OF FRESH FROZEN PLASMA (FFP). STANDARD PREPARATION AND USAGE. NO HIGH PRESSURE OR OTHER PROBLEMS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID INFUSER INFUSION PUMP FRN BELMONT INSTRUMENT CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *