BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2031759 · Received February 25, 2011

    Report

    Report Number
    1212122-2011-00030
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE; HOWEVER, THE COMPLAINT WAS NOT CONFIRMED. THE EVENT WAS MISREPORTED; THE FILTER CONNECTION WAS ASSEMBLED PROPERLY. THE ROOT CAUSE OF THIS EVENT IS DUE TO LAYERING OF THE DEVICE CAUSING THE TWIST CONNECTION NEAR THE ARTERIAL FILTER TO ALTER POSITION, WHICH DID NOT MEET CUSTOMERS EXPECTATIONS. LAYERING WAS PERFORMED ACCORDING TO SPECIFICATION WHICH IS DESIGNED BY THE USER. TERUMO WILL REVIEW LAYERING DURING THE NEXT BUILD. THE COMPLAINT WILL BE INCLUDED IN THE ASSOCIATE AWARENESS TRAINING. 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 THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SET-UP, THE ARTERIAL FILTER IN THE PACK WAS INSIDE OUT. 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 PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION MN15

    Patients

    Seq Age Sex Outcome Treatment
    1