BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE BRAT

    MDR report key: 35029 · Received July 11, 1996

    Report

    Report Number
    35029
    Event Type
    Malfunction
    Date Received
    July 11, 1996
    Date of Event
    June 20, 1996
    Report Date
    July 1, 1996
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MAJOR SPLASH OF BLOOD, FROM CLOGGED TRANSFUSION SYSTEM. TRIPLE A PROCEDURE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE BRAT RAPID AUTOLOGOUS TRANSFUSION SYSTEM CAC COBE CARDIOVASCULAR, INC. SB 412 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR