BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2024012 · Received March 14, 2011

    Report

    Report Number
    1212122-2011-00043
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND THE COMPLAINT WAS CONFIRMED. THE FILTER'S PORT WAS DAMAGED, WHICH WOULD CAUSE LEAKAGE. THE ROOT CAUSE OF THE COMPLAINT IS DAMAGE THAT MAY HAVE OCCURRED DURING SHIPPING OR THROUGH USER HANDLING. TERUMO WILL REVIEW THE NEXT BUILD OF THIS PACK AND WILL RECOMMEND TO SHIP PALLETIZED. 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 PRIME, THE PRE-BYPASS FILTER LEAKED. 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 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