BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGYLE AQUA-SEAL

    MDR report key: 250809 · Received November 18, 1999

    Report

    Report Number
    250809
    Event Type
    Death
    Date Received
    November 18, 1999
    Date of Event
    November 13, 1999
    Report Date
    November 18, 1999
    Manufacturer
    KENDALL CO.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED AFTER AUTO ACCIDENT WITH TRAUMA TO CHEST. CHEST TUBE WAS INSERTED AND CONNECTED TO DRAINAGE UNIT. THE PT WENT TO OR FOR THORACOTOMY. DURING PREPARATION FOR SURGERY SHE HAD A CARDIAC ARREST. AFTER DEATH THE DRAINAGE UNIT WAS FOUND TO BE CLAMPED. IT PROBABLY HAPPENED WHEN SOMEONE LEANED AGAINST THE CLAMP & IT CLOSED. PT HAD 3000CC BLOOD IN CHEST. PT WAS VERY SEVERELY INJURED & HAD A LACERATED VENA CAVA, VENTRICLE & LIVER, BUT THE CLAMP SHOULD NOT BE ABLE TO "CLAMP" SO EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGYLE AQUA-SEAL AUTO TRANSFUSION CHEST DRAINAGE UNIT CAC KENDALL CO. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death