BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1964653 · Received December 23, 2010

    Report

    Report Number
    1212122-2010-00228
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE. THE ROOT CAUSE OF THE EVENT IS DUE TO INCORRECT LAYERING OF THE PACK, CAUSING THE RECIRCULATION LINE TO FLATTEN. THE PACK HAS BEEN REVISED TO REVIEW LAYERING DURING THE NEXT BUILD. 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 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 RECIRCULATION LINE IS COMPLETELY FLATTENED. THE CUSTOMER USED A 1/4 Y CONNECTOR TO BYPASS THE FLATTENED LINE. THERE WERE TWO OCCURRENCES OF THIS EVENT. 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 PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORP. MK23

    Patients

    Seq Age Sex Outcome Treatment
    1