BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATS

    MDR report key: 492294 · Received October 28, 2003

    Report

    Report Number
    3033270-2003-00004
    Event Type
    Death
    Date Received
    October 28, 2003
    Date of Event
    October 10, 2003
    Report Date
    October 22, 2003
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CATS CELL SAVER MACHINE BEING USED IN SURGERY FOR PT HAVING ABDOMINAL AORTIC ANEURYSM REPAIR (STARTED APPROX 1PM). SURGERY COMPLICATED WITH EXCESSIVE BLOOD LOSS (PT RECEIVED APPROX 30 UNITS OF BANK BLOOD). ANESTHESIOLOGIST WAS USING A RAPID INFUSER TO INCREASE SPEED OF BLOOD TRANSFUSIONS AND PERFUSIONIST HAD CATS IN EMERGENCY WASH MODE. APPROX 5 HOURS INTO PROCEDURE (PER PERFUSIONIST) PT'S BP WAS UNSTABLE (MEAN ARTERIAL PRESSURE 40) AND CHEST COMPRESSIONS WERE STARTED TO IMPROVE PERFUSION, PT STILL HAD A HEARTRATE PER EKG. SURGERY CONTINUED DESPITE THIS. CATS HAD FUNCTIONED PROPERLY FOR ABOUT 6 HOURS AND REINFUSED ABOUT 8 UNITS OF PT'S BLOOD. PER PERFUSIONIST, APPROX 20 MIN AFTER CHEST COMPRESSIONS STARTED THE CATS MACHINE DEVELOPED A CENTRIFUGE LEAK. THE PERFUSIONIST CHANGED THE DISPOSABLE, CLEANED OUT THE CENTRIFUGE, LOADED A NEW DISPOSABLE AND TRIED TO RESTART THE CATS MACHINE. SHE WAS UNABLE TO RESTART IT. THERE WAS NO BACK UP CELL SAVER AT THIS INSTITUTION AND THERE WAS ABOUT 6 UNITS OF PT'S BLOOD IN THE CATS RESERVOIR THAT SHE WAS UNABLE TO REINFUSE. THE PT EXPIRED APPROX 15 MINUTES AFTER THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATS CONTINUOUS AUTOTRANSFUSION DEVICE CAC FRESENIUS HEMOCARE, INC. 9005091 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death