BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1882910 · Received October 22, 2010

    Report

    Report Number
    1212122-2010-00186
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 27, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE; THEREFORE, NO PHYSICAL EVAL WAS PERFORMED. THERE HAVE BEEN REPORTS OF KINKED TUBING IN OTHER PACKS DUE TO LAYERING ISSUES. LAYERING HAS BEEN REVISED TO AVOID FUTURE KINKING IN PACKS, AND NO FURTHER ISSUES WERE FOUND. 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 IN FILE IN QUALITY MGMT 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, OUT-OF-BOX, TUBING IS KINKED. THE CUSTOMER HAS REPORTED THAT THIS IS AN ONGOING PROBLEM. 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 NA MG28

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK