BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HQV 29201#CIRCUITO CEC ADULTO

    MDR report key: 5274851 · Received December 8, 2015

    Report

    Report Number
    8010762-2015-01223
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Date of Event
    November 16, 2015
    Report Date
    November 16, 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

    DECEMBER 08, 2015 01:07 PM (GMT-5:00) ADDED BY (B)(6): MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED. THE TESTED PRODUCTS HAS THE SAME LEAKAGE AT THE SAME POSITION. THIS COULD BE DETERMINED AS BONDING FAILURE. (B)(4). WE TESTED THE 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 BONDING BETWEEN COVER AND FILTER BODY. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO CUSTOMER'S INFO: "PRIMING LEAKAGE FROM THE BYPASS SELECTOR OF QUART ARTERIAL FILTER DEVICE DETECTED DURING SYSTEM DE-AIRING - DEVICE REMOVED BEFORE USE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803619 HQV 29201#CIRCUITO CEC ADULTO FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG HQV 29201 92159206

    Patients

    Seq Age Sex Outcome Treatment
    1