BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAT2 PROCEDURE SET

    MDR report key: 496639 · Received November 14, 2003

    Report

    Report Number
    1718850-2003-00023
    Event Type
    Other
    Date Received
    November 14, 2003
    Date of Event
    October 22, 2003
    Report Date
    November 14, 2003
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    CAC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE BLOOD SALVAGE PROCEDURE, BLOOD LEAKED FROM THE INLET LINE TO THE PUMP CARTRIDTGE CONNECTION. BLOOD LEAKED ONTO THE MACHINE AND THE OPERATOR WAS ACCIDENTALLY EXPOSED TO THE PT'S BLOOD LOSS WAS APPROXIMATELY 20CC AND NO INTERVENTION WAS REQUIRED TO COMPENSATE FOR THE BLOOD LOSS. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAT2 PROCEDURE SET AUTOLOGOUS TRANSFUSION DISPOSABLES CAC COBE CARDIOVASCULAR, INC. NA 0324600007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other