BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 2061404 · Received March 18, 2011

    Report

    Report Number
    1212122-2011-00050
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE AND THE COMPLAINT WAS NOT CONFIRMED. PER CLINICAL REVIEW OF THE EVENT, THE HEART/LUNG MACHINE WAS MOST LIKELY BUMPED BY THE USER, CAUSING THE DISCONNECT. THE USER VISUALLY INSPECTED THE CONNECTORS AND ALL PASSED. TERUMO WILL RECOMMEND THAT THE USER SAVE THE PARTS FOR EVALUATION IF AN EVENT OCCURRED AGAIN. TERUMO WILL MONITOR FOR FUTURE ISSUES. THE COMPLAINT WILL BE INCLUDED IN ASSOCIATE AWARENESS TRAINING. NO LOT NUMBER WAS REPORTED; NO DEVICE HISTORY RECORD REVIEW PERFORMED. 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, DURING PRIME, THERE WAS A DISCONNECT AT THE QUICK CONNECTION NEAR THE OUTLET OF THE OXYGENATOR JUST PRIOR TO GOING ON THE PUMP. THE PRODUCT WAS NOT CHANGED OUT, THERE WAS ABOUT 200-300 ML BLOOD LOSS, AND SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE DELAY IN SURGICAL PROCEDURE. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention