BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BO-H 20306#CIRCUITO CEC

    MDR report key: 5779906 · Received July 8, 2016

    Report

    Report Number
    8010762-2016-00432
    Event Type
    Malfunction
    Date Received
    July 8, 2016
    Date of Event
    April 12, 2016
    Report Date
    April 18, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K001787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE TESTED THE RETURNED FILTER IN OUR LABORATORY, FOLLOWING OUR STANDARD PROCESS, ON TIGHTNESS. THEREFORE, THE QUART WAS TESTED AT BELOW WATER IN A WATER BATH AND WAS THEN PRESSURIZED WITH COMPRESSED AIR (0.3 BAR). DUE TO THE AIR ESCAPING (VISIBLE AS AIR BUBBLES IN WATER) A LEAKAGE IN THE WELDING COVER HAS BEEN FOUND. THE LEAKAGE AT THE CONNECTION BETWEEN COVER AND FILTER BODY CAN BE CONFIRMED. MOST POSSIBLE ROOT CAUSE COULD BE THE BAD WELDING BETWEEN COVER AND FILTER BODY. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS AN SYSTEMIC ERROR. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "ACCORDING TO CUSTOMER'S INFO: "DURING A CARDIAC SURGERY PROCEDURE, IT HAPPENED A BLOOD AND PRIME LIQUID LEAKAGE FROM THE ARTERIAL FILTER. SO WE EXCLUDED THE ARTERIAL FILTER WITH THE SHUNT OF THE CIRCUIT AND FINISH THE PROCEDURE." NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432192 BO-H 20306#CIRCUITO CEC FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG BO-H 20306 92176077

    Patients

    Seq Age Sex Outcome Treatment
    1