BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX COMPLETE PACK

    MDR report key: 4290918 · Received November 24, 2014

    Report

    Report Number
    8010762-2014-01317
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    October 31, 2014
    Report Date
    October 31, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG HAS NOT YET RECEIVED THE OXYGENATOR FOR INVESTIGATION. EACH OXYGENATOR IS TESTED ON TIGHTNESS DURING THE PRODUCTION PROCESS (ACCORDING TO BASIC OPERATIONAL PROCEDURE (BOP) 7517). THE TEST IS CARRIED OUT AT 1 BARD (ABOUT 14 PSI) FOR A TIME PERIOD OF 75 MIN AT A FLOW OF 8 L/MIN. DURING THIS TIME THE OXYGENATORS ARE CHECKED FOR ANY LEAKAGES. INVESTIGATION STILL PENDING. ADDITIONAL INFO: THE PRODUCT MENTIONED UNDER SECTION D IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-I) IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERFUSIONIST OBSERVED A POOL OF PRIMING FLUID ON THE FLOOR DURING PRIMING. THE OXYGENATOR APPEARED TO LEAK FROM THE OXYGEN INLET AREA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761861 QUADROX COMPLETE PACK HQV 3300 # QUADROX COMPLETE PACK DTZ MAQUET CARDIOPULMONARY AG HQV 3300 92149848

    Patients

    Seq Age Sex Outcome Treatment
    1