BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCLIP

    MDR report key: 528884 · Received June 4, 2004

    Report

    Report Number
    528884
    Event Type
    Death
    Date Received
    June 4, 2004
    Date of Event
    May 4, 2004
    Report Date
    June 3, 2004
    Manufacturer
    WECK
    Product Code
    DSS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A FEW HOURS AFTER A FIVE VESSEL CORONARY ARTERY BYPASS GRAFT, THE PT DEVELOPED CHEST TUBE DRAINAGE THAT PROGRESSED TOWARD CARDIAC TAMPONADE. WHILE AWAITING TRANSFER TO THE OR PT SELF-EXTUBATED AND IN SPITE OF PROLONGED CPR WAS IN PROLONGED CARDIAC ARREST. PATIENT'S CHEST WAS RE-OPENED, OPEN MASSAGE CARRIED OUT AND PT WAS PLACED ON BYPASS. APPROXIMATELY 100CC CLOT POSTERIOR TO THE HEART WAS OBSERVED, AND A BLEED-SITE FOUND ON A POSTERIOR GRAFT WHICH WAS REPAIRED. THE PT HAD SUFFERED SEVERE ANOXIC BRAIN INJURY AND DEVELOPED CEREBRAL EDEMA WITH BRAIN STEM HERNIATION. PT'S SUPPORT WAS WITHDRAWN AND PT WAS ALLOWED TO EXPIRE. CAUSATIVE FACTORS IN THE PT'S DEATH WERE HEMORRHAGE AND LOSS OF AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCLIP TITANIUM LIGATING CLIP DSS WECK 52380 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death