BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1983325 · Received February 4, 2011

    Report

    Report Number
    1212122-2011-00010
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE, AND THE COMPLAINT WAS CONFIRMED. THE PACK WAS REVISED AND REVIEWED DURING THE NEXT BUILD AND NO ISSUES WERE FOUND. TRAINING WAS PERFORMED WITH ASSOCIATES WHO ASSEMBLED THE PACK. 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 DELPHIN CENTRIFUGAL HEAD WAS BACKWARDS--THE INLET WAS CONNECTED TO THE OXYGENATOR OUTLET, AND THE OUTLET WAS CONNECTED TO THE INLET. THERE WERE 10 OCCURRENCES OF THIS EVENT. THE PRODUCT WAS CHANGED OUT, THERE WAS NO BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE A 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 CORPORATION MP06

    Patients

    Seq Age Sex Outcome Treatment
    1