BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAT

    MDR report key: 1954500 · Received December 13, 2010

    Report

    Report Number
    1954500
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 13, 2010
    Manufacturer
    SORIN COBE
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    FAILURE OF CELL SALVAGE CENTRIFUGE AND BOWL GASKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAT AUTOLOGOUS TRANSFUSION SYSTEM CAC SORIN COBE 007350-000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *