BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2240840 · Received August 16, 2011

    Report

    Report Number
    1212122-2011-00136
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 22, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE, HOWEVER, CUSTOMER AND INVENTORY SAMPLES WERE EVALUATED. TERUMO'S TUBING SUPPLIER PRODUCES VARIATION IN THEIR EXTRUSION PROCESS. TUBING MEETS SPEC AND PASSED DURABILITY TESTING, HOWEVER, THE VARIATION ACCOUNTS FOR THE DIFFERENCES IN WALL THICKNESS, KINKING, AND CLOUDINESS THAT HAVE BEEN REPORTED. THE TUBING SUPPLIER WAS USING A HIGH DRAW DOWN RATIO IN CONJUNCTION WITH LOW TEMPERATURES, WHICH CAUSED CLOUDINESS. EXTRUSION TECHNIQUES CAUSED VARIABILITY IN WALL THICKNESS. COLLECTION METHODS CAUSED TUBING INDENTATION. TERUMO'S TUBING SUPPLIER HAS CHANGED THEIR MFG PROCESS TO ENSURE LIMITED VARIATION IN TUBING PRODUCTION PROCESS. 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 MGMT 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 SET-UP, TUBING WAS CLOUDY. 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 NC28

    Patients

    Seq Age Sex Outcome Treatment
    1