BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGYLE

    MDR report key: 312453 · Received January 8, 2001

    Report

    Report Number
    312453
    Event Type
    Death
    Date Received
    January 8, 2001
    Date of Event
    November 24, 2000
    Report Date
    December 28, 2000
    Manufacturer
    SHERWOOD DAVIS & GECK, SHERWOOD MEDICAL CO, C/O KENDALL HEALTHCARE
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH GUNSHOT WOUNDS TO CHEST. CHEST TUBE SYSTEM PLACED FOR AUTOTRANSFUSION. SHORTLY AFTER BLOOD INFUSED, PT ARRESTED AND DIED. AFTER INVESTIGATION, IT WAS DETERMINED THAT THE COLLECTION CHAMBER HAD NOT BEEN PURGED OF AIR LEADING TO A POSSIBLE AIR EMBOLISM AS CAUSE OF DEATH. AUTOPSY REVEALED OTHER POSSIBLE CAUSES OF DEATH ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024 ARGYLE AUTOTRANSFUSION ACCESSORY UNIT CAC SHERWOOD DAVIS & GECK, SHERWOOD MEDICAL CO, C/O KENDALL HEALTHCARE * 121651

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death| L