BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 4921102 · Received July 15, 2015

    Report

    Report Number
    8010762-2015-00811
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K100287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INVESTIGATION OF A COMPLAINT, AN ADDITIONAL MALFUNCTION WAS FOUND. THIS ADDITIONAL COMPLAINT WAS OPENED IN ORDER TO COVER THE FAILURE. MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS SHOWING A SIMILAR MALFUNCTION AND AN INTERNAL PROCESS ((B)(4)) WAS INITIATED TO DETERMINE THE MOST PROBABLE ROOT CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. THIS DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRACKING AND TRENDING PROCESS. ABBREVIATION NC: NONCONFORMANCE. ADDITIONAL INFO: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510 (K): K100278.

    Description of Event or Problem · 1

    THE PRODUCT WAS INVESTIGATED UNDER COMPLAINT #(B)(4) AND AN ADDITIONAL FAILURE WAS FOUND AS FOLLOWS: DURING A TIGHTNESS TEST OF THE PRODUCT A LEAKAGE AT THE DE-AIRING MEMBRANE WAS DETECTED. THIS ADDITIONAL COMPLAINT WAS OPENED IN ORDER TO COVER THIS FAILURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460514 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BE-HMOD 30000 70102160

    Patients

    Seq Age Sex Outcome Treatment
    1