BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPIRAL GOLD

    MDR report key: 36323 · Received August 21, 1996

    Report

    Report Number
    2026191-1996-00040
    Event Type
    Death
    Date Received
    August 21, 1996
    Date of Event
    August 5, 1996
    Report Date
    August 21, 1996
    Manufacturer
    BENTLEY DIV. BAXTER HEALTHCARE CORP.
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER TERMINATION OF BYPASS FOR CORRECTION OF ACUTE TYPE A AORTIC DISSECTION, PT FAILED TO MAINTAIN ADEQUATE HEMODYNAMICS AND WAS DIAGNOSED WITH RIGHT VENTRICULAR FAILURE AND RESPIRATORY DISTRESS. EMCO WAS INITIATED ON 7/30/96. THERE WAS NOT ENOUGH IMPROVMENT TO SUSTAIN ADEQUATE HEMODYNAMICS WITHOUT ECMO. ECMO WAS DISCONTINUED AT DIRECTION OF FAMILY AND SURGEON AND PT EXPIRED ON 8/5/96. DURING ECMO, TEN (10) OXYGENATORS WERE USED. EACH PERFORMED WELL FOR SIX TO EIGHT HOURS BEFORE DEVELOPING PLASMA LEAKS. ONE STARTED TO LEAK AFTER FOUR HOURS. FOUR OXYGENATORS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIRAL GOLD OXYGENATOR DTZ BENTLEY DIV. BAXTER HEALTHCARE CORP. SPIRAL GOLD 968160

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death