BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE BRAT 2 AUTOLOGOUS TRANSFUSION SYSTEM

    MDR report key: 220931 · Received April 21, 1999

    Report

    Report Number
    1718850-1999-00005
    Event Type
    Death
    Date Received
    April 21, 1999
    Date of Event
    March 8, 1999
    Report Date
    March 23, 1999
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    CAC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE AUTOLOGOUS TRANSFUSION SYSTEM WAS BEING USED TO SALVAGE AND PROCESS BLOOD DURING AN ORTHOPEDIC PROCEDURE. AFTER USE OF THE EQUIPMENT WAS COMPLETE, THE REINFUSION BAG WAS DISCONNECTED AND ITS CONTENTS WERE INFUSED INTO THE PT WITH THE AID OF A PRESSURIZED REINFUSION SYSTEM. THE HOSP HAS ALLEGED THAT THIS ACTION RESULTED IN AIR EMBOLISM TO THE PT AND POSSIBLY CONTRIBUTED TO THE DEATH OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE BRAT 2 AUTOLOGOUS TRANSFUSION SYSTEM AUTOLOGOUS TRANSFUSION EQUIPMENT CAC COBE CARDIOVASCULAR, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death