BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTINUOUS AUTO-TRANSFUSION SYSTEM

    MDR report key: 1013101 · Received March 14, 2008

    Report

    Report Number
    3004152132-2008-00001
    Event Type
    Death
    Date Received
    March 14, 2008
    Date of Event
    February 16, 2008
    Report Date
    February 27, 2008
    Manufacturer
    FRESENIUS NPBI INTERNATIONAL
    Product Code
    CAC
    PMA / PMN Number
    K984586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED IN THE UNITED STATES. THE US AGENT FOR THE PRODUCT IN REGARDS TO REPORTING TO THE FDA IS FRESENIUS KABI, LLC. THE DISPOSABLE USED IN THIS PROCEDURE WILL NOT BE SENT BACK TO THE MANUFACTURER AS IT WAS NOT RETAINED. THE CATS DEVICE WAS OPERATING WITHOUT ANY PROBLEM. THE DEVICE WAS USED ACCORDING TO THE LABELED INDICATION, IN THE APPROPRIATE ENVIRONMENT.

    Description of Event or Problem · 1

    A PATIENT WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM EXPIRED IN THE OPERATING ROOM WHILE THE CATS AUTOTRANSFUSION DEVICE WAS BEING USED. IT WAS NOTED THAT A SUCTION TIP (MANUFACTURED BY YANKAURER) HAD COME OFF OF THE ATS SUCTION LINE. IT WAS STATED BY THE NURSE THAT THE SUCTION TIP FALLING OFF THE SUCTION LINE CAUSE DIFFICULTY TO SUCTION, BUT WAS NOT THE CAUSE OF DEATH. SHE STATED THAT MORBIDITY IS HIGH IN THESE CASES. DURING THE PROCEDURE, THE CATS DEVICE WAS REPORTED TO BE OPERATING WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS AUTO-TRANSFUSION SYSTEM ATF 120 FAST START KIT (DISPOSABLE) CAC FRESENIUS NPBI INTERNATIONAL 9108501 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death