BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2022011 · Received March 10, 2011

    Report

    Report Number
    1212122-2011-00044
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 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

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE; THEREFORE NO PHYSICAL INVESTIGATION WAS PERFORMED. A REVIEW OF THE SPECIFICATION CONFIRMED THAT THE CONNECTOR WAS DRAWN INSIDE THE AV LOOP HEADER BAG. THE ROOT CAUSE OF THE COMPLAINT IS DUE TO LAYERING BUILT PER SPECIFICATION WHICH IS DESIGNED BY THE CUSTOMER. TERUMO HAS REVISED THIS PACK BASED ON CUSTOMER PREFERENCE. THE COMPLAINT WILL BE INCLUDED IN 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 CUSTOMER WAS NOT SATISFIED WITH THE PLACEMENT OF THE 3/8 HALF INCH CONNECTOR IN THE PACK; IT WAS IN THE AV (ARTERIAL VENOUS) LOOP BAG. THE PRODUCT WAS NOT 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 NA03

    Patients

    Seq Age Sex Outcome Treatment
    1