BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATS PLUS AUTOTRANSFUSION SYSTEM

    MDR report key: 1851012 · Received September 29, 2010

    Report

    Report Number
    3004152132-2010-00004
    Event Type
    Death
    Date Received
    September 29, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 28, 2010
    Manufacturer
    FRESENIUS KAB AG
    Product Code
    CAC
    PMA / PMN Number
    K960006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE US AGENT FOR THE PRODUCT IN REGARDS TO FDA REPORTING IS FRESENIUS KABI, LLC IN (B)(4). THE CATS PLUS DEVICE WAS EVALUATED BY A TERUMO TECHNICIAN AND FOUND TO BE WITHIN SPEC. THE 2 DISPOSABLE SETS (ATF 120 FAST START KIT P/N 9108501 LOT # ZFT303) WILL BE SENT BACK TO MFR FOR EVAL. A FOLLOW UP REPORT WILL BE GENERATED WHEN RESULTS ARE RECEIVED. SEE REPORT 3004152132-2010-00005, AS IT DEALS WITH THIS SAME INCIDENT.

    Description of Event or Problem · 1

    THE FRESENIUS C.A.T.S. AUTOTRANSFUSION SYSTEM (C.A.T.S PLUS DEVICE (B)(4) AND ATF 120 FAST START KIT, LOT # ZFT303) WAS USED DURING AN EMERGENT, SALVAGE RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM (AAA). THE OPERATOR BEGAN TO PROCESS SHED BLOOD. AFTER 300 MLS OF PACKED RED BLOOD CELLS (PRC) HAD BEEN PROCESSED WITH THE DEVICE AND KIT, HE EXPERIENCED A "BLOOD FLOW ALARM" ON THE DEVICE. HE ATTEMPTED TO RE-START THE PROCESS UNSUCCESSFULLY. SO HE CHANGED OUT THE PROCESSING DISPOSABLE AND THE DEVICE (HE DID NOT CHANGE OUT THE COLLECTION RESERVOIR WITH THE COLLECTED SHED BLOOD). NEW DEVICE (B)(4) AND A NEW ATF 120 LOT # ZFT303. HE PRIMED THE CHANGED OUT DEVICE AND DISPOSABLE WHEN THE ANEURYSM RUPTURED, THERE WAS 3000ML OF BLOOD THAT WAS QUICKLY ASPIRATED TO THE COLLECTION RESERVOIR. THE OPERATOR GOT BEHIND ON THE HEPARIN LEVELS AND EXPERIENCED CLOTTING OF THE RESERVOIR AND PUMP, EVEN AFTER REDUCING THE VACUUM LEVEL ON THE RESERVOIR. THE BLOOD CLOTTED IN THE COLLECTION RESERVOIR AND WASH KIT. THIS WAS CONFIRMED BY A COLLAPSE IN THE TUBING BETWEEN THE RESERVOIR AND THE PUMP. THE LACK OF THE ANTICOAGULANT AND BLOOD CLOTS WILL CAUSE THE DEVICE TO RESPOND WITH "BLOOD FLOW ALARMS", WHICH WAS OBSERVED DURING THIS CASE DURING THE PROCEDURE AS NOTED IN THE OPERATOR MANUAL. THE PT WAS TRANSFUSED LARGE VOLUMES OF HOMOLOGOUS BLOOD. THIS INCLUDED RED BLOOD CELLS (RBC), PLATELETS, AND FRESH FROZEN PLASMA (FFP). THESE WERE GIVEN DUE TO LARGE VOLUMES OF BLEEDING RESULTING FROM THE RUPTURED ANEURYSM. THE SURGICAL AND ANESTHESIA TEAM STATED THE CLOTTING ISSUE, AND DEVICE DID NOT HAVE AN EFFECT ON THE PT'S CONDITION. IN SPITE OF ALL EFFORTS, THE PT EXPIRED OVER THREE HOURS AFTER THIS SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATS PLUS AUTOTRANSFUSION SYSTEM CELL SAVER CAC FRESENIUS KAB AG 9005081 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death