BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2182363 · Received July 11, 2011

    Report

    Report Number
    1212122-2011-00117
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    June 16, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE; HOWEVER, THE COMPLAINT WAS CONFIRMED BASED ON VISUAL REVIEW OF THE DEVICE HISTORY RECORD. LAYERING WAS CHANGED IN RESPONSE TO A PREVIOUS COMPLAINT WHERE LAYERING MAY HAVE AFFECTED THE ISSUE REPORTED. PER INTERNAL PROCEDURE, CUSTOMER APPROVAL IS NOT REQUIRED TO CHANGE LAYERING UNLESS OTHERWISE SPECIFIED. LAYERING HAS BEEN REVISED AND SPECIFIES THAT THE ORDER IS PER CUSTOMER REQUEST. 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, OUT-OF-BOX, THE PACKS WERE LAYERED INCORRECTLY. 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 NE18

    Patients

    Seq Age Sex Outcome Treatment
    1