BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    01971100#QUADROX-I

    MDR report key: 3902081 · Received February 24, 2014

    Report

    Report Number
    8010762-2014-00073
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 15, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER PERFORMING A TIGHTNESS TEST ACCORDING TO OUR STANDARD PROCEDURE, LEAKAGE FROM THE DEAIRING PORT WAS CONFIRMED. THE PORT WAS FURTHER INVESTIGATED UNDER OPTICAL MICROSCOPE. WATER LEAKAGE ON THE EDGE OF THE DEAIRING MEMBRANE UNDER THE ADHESIVE BEAD WAS OBSERVED, IN ADDITION TO THAT, BIG HOLES WERE LOCALIZED IN THE DEAIRING MEMBRANE BODY. THE EXACT ROOT-CAUSE OF THE LEAK IS NOT KNOWN AT THE MOMENT. EACH OXYGENATOR IS TESTED DURING PRODUCTION FOR TIGHTNESS. A REVIEW OF THE MFG RECORDS SHOWED THAT THIS OXYGENATOR HAD PASSED SUCCESSFULLY THER FINAL 100% TEST. NO MORE COMPLAINTS FROM THE SAME LOT WERE RECEIVED. AN INVESTIGATION HAS BEEN INITIATED FOR CORRECTIVE AND PREVENTATIVE ACTION.

    Description of Event or Problem · 1

    DURING CPB THERE WAS, AT THE BEGINNING OF PERFUSION, BLOOD LEAKAGE FROM THE DE-AIRING PORT OF THE OXYGENATOR. NO CHANGE IN PT STATUS WAS NOTICED DURING THE REST OF THE PROCEDURE. THE OXYGENATOR WAS NOT CHANGED AND WAS 100% FUNCTIONAL. LEAKAGE WAS DRIP WISE FOR THE WHOLE PROCEDURE, NOT ENHANCED. REF:# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114381 01971100#QUADROX-I MICROPOROUS MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70103.1736 70091497

    Patients

    Seq Age Sex Outcome Treatment
    1 NI