BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPIOX SX18 OXYGENATOR

    MDR report key: 648934 · Received December 1, 2005

    Report

    Report Number
    1124841-2005-00022
    Event Type
    Death
    Date Received
    December 1, 2005
    Date of Event
    November 1, 2005
    Report Date
    November 1, 2005
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIOPULMONARY BYPASS SURGERY, THE OXYGENATOR DEVICE EXHIBITED REDUCED GAS TRANSFER PERFORMANCE AS EVIDENCE BY LOW PO2 LEVELS. NOTE: THE USER FACILITY REPORTED THAT THE PT WAS UNDERGOING A LIVER TRANSPLANT (SECOND TRANSPLANT IN TWO DAYS) WHEN SHE EXPERIENCED CARDIAC ARREST. EMERGENT PROCEDURES WERE EMPLOYED-INDUCING CPR-AND THE PT WAS SUBSEQUENTLY PLACED ON HEART BYPASS. WHITE ON EXTRACORPOREAL CIRCULATION, THE PT EXPIRED. THERE IS NO EVIDENCE TO SUGGEST THAT THE OXYGENATOR DEVICE CAUSED AND/OR CONTRIBUTED TO THE PT'S DEATH. THE USER FACILITY REPORTS THAT THE PT EXPIRED DUE TO LIVER-RELATED CONDITIONS, RENAL FAILURE AND CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX SX18 OXYGENATOR OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA FH11

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death