BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1961501 · Received January 10, 2011

    Report

    Report Number
    1212122-2011-00004
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    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

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE; HOWEVER, A VISUAL EXAMINATION OF PHOTOGRAPHIC IMAGES RECEIVED FOR THE COMPLAINT CONFIRMED THE KINK IN TUBING. THE DELPHIN PUMP AND VELCRO WERE PLACED IN THE INCORRECT LOCATION, CAUSING A KINK IN TUBING. TERUMO HAS REVISED LAYERING AND SPECS FOR THIS PACK, AND HAS TRAINED ASSOCIATES INVOLVED IN ASSEMBLY OF THIS 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 F/U. (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 TUBING WAS KINKED AT THE OUTLET OF THE CENTRIFUGAL PUMP. THE PRODUCT WAS NOT USED IN CARDIOPULMONARY BYPASS SURGERY. 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 ML27

    Patients

    Seq Age Sex Outcome Treatment
    1