BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2033112 · Received February 28, 2011

    Report

    Report Number
    1212122-2011-00032
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 3, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1212122-02-03-2011-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE, HOWEVER, THE COMPLAINT WAS CONFIRMED. A DEVICE FROM CONTROLLED/NON-RELEASED INVENTORY WAS PRESSURE TESTED AND THE LEAK WAS CONFIRMED AT VARYING PRESSURES AND TIMES. THE ROOT CAUSE OF THIS ISSUE HAS BEEN IDENTIFIED AS A DECREASED DIMENSIONAL TAPER UTILIZED BY TERUMO'S SUPPLIER'S MANUFACTURING PROCESS, CAUSING AN INCONSISTENT SEAL BETWEEN THE FEMALE AND MALE LUER ADAPTERS. AS SHORT-TERM AND IMMEDIATE CORRECTIVE ACTION MEASURES, TERUMO HAS CONDUCTED A HAZARD/RISK ANALYSIS ASSESSMENT TO ADDRESS THE IDENTIFIED MODE OF FAILURE. TERUMO'S SUPPLIER HAS MODIFIED THE CORE PIN TO REDUCE THE INNER DIAMETER OF THE LUER TAPER. ADDITIONALLY, BOTH TERUMO'S SUPPLIER AND TERUMO CARDIOVASCULAR SYSTEMS HAVE IMPLEMENTED MORE STRINGENT INSPECTIONS OF THE FEMALE LUER ADAPTERS TO ENSURE CONTINUED EFFECTIVENESS OF THE APPLIED CORRECTIVE ACTION. TERUMO (B)(4) IS MODIFYING THE INCOMING RAW MATERIAL INSPECTION PROCESS TO ADDRESS HOW THE DEFECT WAS NOT DETECTED. 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 CONNECTOR ON THE DELIVERY LINE LEAKS. THE PRODUCT WAS NOT CHANGED OUT, THERE WAS 2 ML 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 MN08

    Patients

    Seq Age Sex Outcome Treatment
    1