BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLEUR-EVAC AUTOTRANSFUSION SYSTEM

    MDR report key: 28749 · Received November 17, 1995

    Report

    Report Number
    1483039-1995-00023
    Event Type
    Death
    Date Received
    November 17, 1995
    Date of Event
    October 11, 1994
    Report Date
    November 16, 1995
    Manufacturer
    DEKNATEL, INC.
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PER LAWSUIT: AUTOTRANSFUSION SYSTEM WAS USED DURING OPEN HEART SURGERY. SHORTLY AFTER SURGERY, DECEDENT SUFFERED A CARDIAC ARREST, WAS UNABLE TO BE RESUSCITATED, AND EXPIRED DUE TO A MASSIVE AIR EMBOLISM. THIS REPORT IS BASED ON INFO OFFERED IN A CIVIL LAWSUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUR-EVAC AUTOTRANSFUSION SYSTEM CHEST DRAINAGE & AUTOTRANSFUSION SYSTEM CAC DEKNATEL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death