BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR W/HARDSHELL RESERVOIR

    MDR report key: 1853110 · Received September 22, 2010

    Report

    Report Number
    1124841-2010-00124
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K051997
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND VISUAL INSPECTION CONFIRMED THAT THE TUBING WAS KINKED INSIDE THE VENOUS FILTER. THE UNUSED SAMPLE THAT WAS ALSO RETURNED DID NOT DISPLAY ANY EVIDENCE OF KINKED TUBING DURING VISUAL INSPECTION. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS FOR THIS LOT. THE DEVICE HISTORY RECORD DID NOT INDICATE ANY PRODUCTION RELATED PROBLEMS. ALL AVAILABLE INFO 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 THAT DURING CARDIOPULMONARY BYPASS SURGERY THAT THEY WERE GETTING HIGH LINE PRESSURES FROM THE RESERVOIR. THE USER FACILITY STATED THIS OCCURRENCE TWICE; HOWEVER, THE SECOND UNIT ONLY DISPLAYED A SLIGHTLY HIGHER PRESSURE AND THEY WERE ABLE TO OVERCOME IT WITH ADDITIONAL VACUUM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX RX OXYGENATOR W/HARDSHELL RESERVOIR BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA MG01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK