BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTINUOUS AUTO TRANSFUSION SYSTEM

    MDR report key: 3254004 · Received July 26, 2013

    Report

    Report Number
    3004548776-2013-00003
    Event Type
    Death
    Date Received
    July 26, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 1, 2013
    Manufacturer
    FRESENIUS-KABI
    Product Code
    CAC
    PMA / PMN Number
    K973378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO CONFIRM THE ORIGINAL PROBLEM OF "CLOTTED RESERVOIR" AND A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE DEVICE PROBLEM WAS DUE TO DAMAGE TO THE INSTRUMENT AS THEY WERE ATTEMPTING TO REPLACE THE DISPOSABLE UNIT DURING THE PROCEDURE. THE DEVICE WAS SERVICED FOR BENT PINS ON THE CHAMBER COVER AND FOUND TO BE DAMAGED BY THE USER FACILITY DURING THE REMOVAL AND REINSTALLATION OF THE DISPOSABLE SET DURING THE PROCEDURE. AFTER THE REPAIR THE UNIT WAS TESTED SUCCESSFULLY AND NO ANOMALIES WERE IDENTIFIED OUTSIDE OF THE DAMAGED PIN ON THE CHAMBER COVER. (B)(4) WILL ADVISE TERUMO TO HAVE A CLINICAL SPECIALIST REVIEW USAGE OF DEVICE AND SITUATIONS AS LISTED IN THIS REPORT.

    Description of Event or Problem · 1

    AN (B)(6) YEAR OLD MALE, EXPIRED DURING HERNIA REPAIR AS SURGEON INJURED THE AORTA. LARGE AMOUNT OF BLOOD LOSS, 3000ML COLLECTED BUT CLOTTED IN RESERVOIR. NEW RESERVOIR SET UP BUT WHEN PROCESSING STARTED TUBING DAMAGED BY BENT PINS OF CHAMBER COVER, PATIENT EXPIRED IN THE INTERIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350727 CONTINUOUS AUTO TRANSFUSION SYSTEM C.A.T.S. CAC FRESENIUS-KABI

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death