BEUDAMED
    FDA Adverse Event Death Summary report: N

    C.A.T.S AUTOTRANSFUSION SYSTEM

    MDR report key: 226955 · Received June 11, 1999

    Report

    Report Number
    2953759-1999-00002
    Event Type
    Death
    Date Received
    June 11, 1999
    Date of Event
    May 10, 1999
    Report Date
    May 10, 1999
    Manufacturer
    FRESENIUS AG WERK SCHWEINFURT
    Product Code
    CAC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A TRIPLE A (ABDOMINAL AORTIC ANEURYSM), THE TUBING OF THE AT1 DISPOSABLE TUBING SET SHEARED OFF AT THE BASE OF THE CENTRIFUGE DURING USE, RESULTING IN LOSS OF 1200 CC OF UNWASHED BLOOD CONTAINED IN THE AUTOTRANSFUSION RESERVIOR DUE TO POTENTIAL CONTAMINATION AND BECAUSE THE BLOOD COULD NOT BE PROCESSED BY THE AUTOTRANSFUSION SYSTEM. THE DEFECTIVE SET WAS REMOVED AND A NEW SET WAS INSTALLED, BUT THE AUTOTRANSFUSION SYSTEM WOULD NOT FUNCTION DUE TO A SIGNIFICANT AMOUNT OF BLOOD IN THE CENTRIFUGE CHAMBER. THE EVENT OCCURRED 1.5 TO 2 HRS AFTER THE PROCEDURE WAS STARTED. THE MACHINE ALARMED APPROPRIATELY. THE PT REQUIRED TRANSFUSION OF 12 UNITES OF BLOOD. THE PT EXPIRED WITHIN 48 HRS OF THE EVENT, ALTHOUGH THIS WAS AN ANTICIPATED RESULT WITH RESPECT TO THE PT DIAGNOSIS. THE CAUSE OF DEATH WAS THE ABDOMINAL AORTIC ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.A.T.S AUTOTRANSFUSION SYSTEM AUTOTRANSFUSION DEVICE CAC FRESENIUS AG WERK SCHWEINFURT C.A.T.S AUTOTRANSFUSION SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death (05/10/1999 TO 05/10/1999).| FRESENIUS AT1 SET, PN 9005301, LOT IDW 242 2