BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2182390 · Received July 11, 2011

    Report

    Report Number
    1212122-2011-00129
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    June 16, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND THE COMPLAINT WAS CONFIRMED. THE COMPLAINT WAS MISREPORTED, THE PACK INVOLVED IN THE EVENT REPORTED WAS A 3-WAY STOPCOCK. NO FAILURES WERE OBSERVED THROUGH PRESSURE TESTING. THE SAMPLE ONLY FAILED WHEN THE HANDLE WAS ROTATED TO THE FOURTH POSITION, PAST THE HOUSING STOP. THE ROOT CAUSE OF THIS EVENT IS CUSTOMER TECHNIQUE DAMAGING THE PART RESULTING IN LEAKAGE. THE PACK HAS BEEN REVISED TO INCLUDE 4-WAY ROTATABLE STOPCOCKS. THE COMPLAINT WILL BE INCLUDED IN ASSOCIATE AWARENESS TRAINING. NO LOT NUMBER WAS REPORTED; THEREFORE, NO DEVICE HISTORY RECORD REVIEW WAS PERFORMED. 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 PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE CUSTOMER EXPERIENCED A LEAKY 4-WAY STOPCOCK. THE PRODUCT WAS CHANGED OUT, THERE WAS NO BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE DELAY IN SURGICAL PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1