BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX SX OXYGENATOR W/HARDSHELL RESERVOIR

    MDR report key: 1952116 · Received January 4, 2011

    Report

    Report Number
    1124841-2010-00250
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 14, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K993772
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND UPON EVALUATION OF THE DEVICE, THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE COMPLAINT FILES DID NOT CONFIRM THAT THERE HAVE BEEN OTHER REPORTS FOR THIS LOT. THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING CARDIOPULMONARY BYPASS, THE VENOUS LINE FAILED TO DRAIN INTO THE RESERVOIR. THE PRODUCT WAS CHANGED OUT. THERE WAS 400CC'S OF BLOOD LOSS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX SX OXYGENATOR W/HARDSHELL RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA MG14

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention