BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX-I- OXYGENATOR

    MDR report key: 3924997 · Received June 17, 2014

    Report

    Report Number
    8010762-2014-00239
    Event Type
    Death
    Date Received
    June 17, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET IS AWARE OF SIMILAR COMPLAINTS. THE DEVICES DISPLAYED A SIMILAR MALFUNCTION WHICH WAS TESTED AND EVALUATED UNDER NA OPTICAL MICROSCOPE. DELAMINATION OF SOME GAS FIBERS WAS OBSERVED WHICH ALLOWED FOR THE PRIMING SOLUTION OR BLOOD TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE. GRAVITY THEN ALLOWED FOR PASSAGE TO THE GAS EXITING PATH ALONG THE HOUSING. THE MOST PROBABLE ROOT-CAUSE IS THE DELAMINATION OF THE HOLLOW GAS FIBERS FROM THE POLYURETHANE POTTING AREA. MAQUET HAS INITIATED AN INTERNAL PROCESS (CAPA-(B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD WAS FOUND DRIPPING FROM THE GAS OUTLET AFTER APPROX ONE HOUR OF USE. DEVICE CHANGE OUT WAS PREPARED BUT NOT ACCOMPLISHED. PT WAS TOO UNSTABLE. VENTRICULAR RUPTURE WAS SUSPECTED. THERAPY WAS TERMINATED. PT EXPIRED UNDER RESUSCITATION CONDITIONS. ADD'L INFO RECEIVED ON (B)(6) 2014: "BLOOD FLOW (TOTAL): 3.68 1/MIN, ROTATION: 4144/MIN, GAS FLOW: 2.0 1/MIN, FIO2: 1.0%, NO ARTERIAL DEPOSITS, ACT (ANTI COAGULATION TIME) 220. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355955 QUADROX-I- OXYGENATOR MICROPOROSE MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70098206

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death