BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX-ID ADULT DIFFUSION MEMBRANE OXY.

    MDR report key: 4282947 · Received November 27, 2014

    Report

    Report Number
    8010762-2014-01131
    Event Type
    Death
    Date Received
    November 27, 2014
    Date of Event
    November 13, 2011
    Report Date
    November 28, 2011
    Manufacturer
    MAQUET CARDIOPULMOARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED SAMPLE WAS ANALYZED IN THE LABORATORY AND THE LEAKAGE AT THE GAS EXHAUST PORT WAS CONFIRMED. THE LEAK WAS CAUSED DUE TO ABLATION OF THE POLYURETHANE. THE ENDS OF THE GAS FIBERS ARE EMBEDDED IN POLYURETHANE AND THERE WAS A LEAK IN THE POLYURETHANE ADHESION. THE CAUSE OF THE ABLATION OF THE POLYURETHANE IS NOT DETERMINED AT THIS TIME AND AN INVESTIGATION IS ONGOING. NOTE: THE REPORTED EVENT OCCURRED WHEN USING THE BE-01970311-PLS D OXYGENATOR, HOWEVER A EQUIVALENT DEVICE MARKETED IN THE U.S. IS USED FOR REPORTING. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, AT (B)(6) IN (B)(6), IT WAS REPORTED THAT DURING AN ECMO PROCEDURE, THERE WAS LIMITED OXYGENATION THAT HAD NO IMPACT ON SPO2 AND THERE WAS BLOOD LEAKAGE FROM THE GAS OUTLET OF THE QUADROX-I BE-01970311-PLS D OXYGENATOR (LOT NUMBER 70065371). THE OXYGENATOR WAS REPLACED. AFTER A SUCCESSION OF HEART STOPS THE PATIENT RECOVERED A SUBNORMAL HAEMODYNAMIC STATE FOR 30 MINUTES. AFTER THE LAST HEART STOP, THE PATIENT EXPIRED. AT THIS MOMENT THE USER NOTICED A IMPORTANT BLOOD LEAKAGE AT THE GAS OUTLET. THIS EVENT WAS REPORTED BY THE CUSTOMER TO (B)(4) ON (B)(4) 2011, REPORT NUMBER (B)(4). THIS EVENT WAS REPORTED BY (B)(6) TO THE (B)(4) ON (B)(4) 2012, AND A FINAL REPORT WAS SUBMITTED ON 04/03/2012. REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770647 QUADROX-ID ADULT DIFFUSION MEMBRANE OXY. OXYGENATOR, CARDIOPULMONARY BY-PASS DTZ MAQUET CARDIOPULMOARY AG 70105.0758 70065371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention