BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX-I ADULT WITH VENOUS HARDSHELL CARDIOTOMY RESERVOIR

    MDR report key: 4944812 · Received July 28, 2015

    Report

    Report Number
    8010762-2015-00474
    Event Type
    Death
    Date Received
    July 28, 2015
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE RETURNED SAMPLE WAS ANALYZED BY PRESSURE TESTING IN THE LABORATORY AND THE EXCHANGE PERFORMANCE OF CARBON DIOXIDE WAS 36 ML/L WHICH IS BELOW THE REQUIRED MINIMUM LEVEL OF 38 ML/L AT MAXIMUM FLOW OF 7 L/MIN. THIS CAN BE EXPLAINED FROM THE CLOTTED AREA SEEN IN THE OXYGENATOR AFTER RECEIVING THE DEVICE FOR INVESTIGATION. THE CLOTTED AREA ACTED AS A BARRIER AND PREVENTED THE BLOOD FROM REACHING THE GAS FIBERS AND HENCE MINIMIZED THE CO2 TRANSFER EFFICIENCY. IN CASE OF THE DESCRIBED EMERGENCY TREATMENT WITH A HIGH RATE OF TRANSFUSION (RBC, FFPS AND THROMBOCYTES) THE RISK OF CLOTTING INCREASES EXTRAORDINARY IN ANY KIND OF EXTRACORPOREAL SUPPORT (ECLS) AND CONTACT TO FOREIGN BODIES. AN ANTICOAGULANT, LIKE RECOMMENDED WHILE ECLS WAS NOT POSSIBLE IN THIS CASE AND SO CLOTTING MIGHT HAVE BEEN UNAVOIDABLE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014 AT THE (B)(6) IN THE (B)(6) IT WAS REPORTED THAT THE QUADROX-I ADULT HMO 70000 + VHK 71000 OXYGENATOR FROM LOT NUMBER 70095062 WAS NOT OXYGENATING DURING A PERFUSION PROCEDURE. AT FIRST, THE OXYGENATOR PERFORMED WELL BUT AFTER THE PATIENT WAS TRANSFUSED WITH RBC, FFP AND TROMBOCYTES, THE OXYGEN SATURATION (PO2) WAS VERY LOW (7.2 KPA) AND THE PH OF THE BLOOD WAS 7.02 AND LACTATE LEVELS WERE HIGH. THE PATIENT WAS CONNECTED TO A CARDIOHELP AND MOVED TO THE ICU. IT WAS REPORTED THAT LATER ON THE PATIENT DIED IN THE ICU . (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489216 QUADROX-I ADULT WITH VENOUS HARDSHELL CARDIOTOMY RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG QUADROX-I ADULT HMO 70000 + VHK 71000 70095062

    Patients

    Seq Age Sex Outcome Treatment
    1 Death