BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1944756 · Received December 10, 2010

    Report

    Report Number
    1212122-2010-00226
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE; THEREFORE, NO PHYSICAL INVESTIGATION WAS PERFORMED. TERUMO LOAD RECORDS INDICATE THAT THE DEVICE WAS STERILIZED. ETO TAPE IS NOT VERIFIED BY TERUMO; THEREFORE, THE ROOT CAUSE OF THE EVENT IS UNKNOWN. TERUMO WILL MONITOR FOR FUTURE ISSUES. 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 SET-UP, THE ETO (ETHYLENE OXIDE) STERILIZATION STRIPS, WHICH SERVE AS A VISUAL INDICATOR, DID NOT ALL CHANGE COLOR. QUALITY IN TERUMO (B)(4) WAS CONTACTED AND THE PACK'S STERILITY WAS CONFIRMED BASED ON STERILIZATION RECORDS. THE PRODUCT WAS CHANGED OUT, THERE WAS NO BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID 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 MK30

    Patients

    Seq Age Sex Outcome Treatment
    1