BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1972660 · Received January 20, 2011

    Report

    Report Number
    1212122-2011-00003
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND THE COMPLAINT WAS NOT CONFIRMED. PRESSURE TESTING WAS CONDUCTED ACROSS THE DOME MEMBRANE AND LUER CONNECTOR, AND NO LEAKS OR PRESSURE DROPS WERE DETECTED. TERUMO WILL MONITOR FOR FUTURE ISSUES. THE COMPLAINT WILL BE INCLUDED IN ASSOCIATE AWARENESS TRAINING. 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 F/U. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE ISOLATOR DOME LEAKS AND DOES NOT HOLD PRESSURE. THERE WERE 5 OCCURRENCES OF THIS EVENT. THE PRODUCT WAS CHANGED OUT, THERE WAS NO BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE DELAY IN SURGICAL PROCEDURE. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION MK30T

    Patients

    Seq Age Sex Outcome Treatment
    1