BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1982375 · Received January 14, 2011

    Report

    Report Number
    1212122-2011-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND THE COMPLAINT WAS CONFIRMED. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR), WHICH DETECTS THE MOLECULAR STRUCTURE OF MATERIALS, DETECTED THAT THE FOREIGN MATTER'S MOLECULAR STRUCTURE CLOSELY MATCHED THE MOLECULAR STRUCTURE OF THE Y CONNECTOR. THEREFORE, THE FTIR RESULTS SUGGEST THAT THE FOREIGN MATTER ORIGINATED FROM THE Y CONNECTOR, AND WAS INTRODUCED IN THE TUBING WHEN THE SURGEON CUT THE TUBING AND Y CONNECTOR PRIOR TO CARDIOPULMONARY BYPASS SURGERY. 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 PRIME, THE SURGEON CUT THE 3/8" TUBING IN THE TABLE PACK, PROCEEDED TO CONNECT TUBING WITH THE CANNULAE, AND NOTICED A PIECE OF PLASTIC FLOATING IN THE PRIME SOLUTION. THE PLASTIC WAS REMOVED WITH FORCEPS. 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 ML27

    Patients

    Seq Age Sex Outcome Treatment
    1