BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE CARDIOVASCULAR INC.

    MDR report key: 258206 · Received January 7, 2000

    Report

    Report Number
    258206
    Event Type
    Injury
    Date Received
    January 7, 2000
    Date of Event
    December 4, 1999
    Report Date
    December 7, 1999
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEMBRANE OXYGENATOR. DURING CARDIOPULMONARY BYPASS (CPB) A LEAK WAS NOTED IN THE OUTLET CONNECTOR OF THE RACEWAY TUBING BEFORE OXYGENATOR. THE ARTERIAL LINE PRESSURE AFTER OXYGENATOR WAS WITHIN THE EXPECTED LEVELS. THE DEVICE WAS PERFORMING APPROPRIATELY. BECAUSE OF HIGH PRESSURES IN THE PRE-OXYGENATOR LINES, BLOOD FLOW HAD TO BE DECREASED. PT TEMPERATURE WAS LOWERED TO 20/22 CENTIGRADE. CPB WAS STOPPED AND THE OXYGENATOR WAS REPLACED. PT WAS OFF CPB FOR APPROXIMATELY 30 SECONDS AT 20/22 CENTIGRADE. CPB WAS RE-INITIATED WITH NO FURTHER PROBLEMS. PT WAS SUCCESSFULLY WEANED FROM CPB AND WAS TRANSPORTED TO CORONARY CARE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CARDIOVASCULAR INC. MEMBRANCE OXYGENATOR DTZ COBE CARDIOVASCULAR, INC. 050212000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention