BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BO-H 92101#CIRCUITO CEC

    MDR report key: 5294932 · Received December 14, 2015

    Report

    Report Number
    8010762-2015-01249
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    November 30, 2015
    Report Date
    November 30, 2015
    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). MAQUET (B)(4) IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED. 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. 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 "PRIMING LEAKAGE FROM THE FILTER LOWER SECTION (BY-PASS SELECTOR AREA)." NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823883 BO-H 92101#CIRCUITO CEC FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG BO-H 92101 92181373

    Patients

    Seq Age Sex Outcome Treatment
    1