BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLOSEAL MATRIX HAEMOSTATIC SEALANT

    MDR report key: 1031471 · Received April 17, 2008

    Report

    Report Number
    1031471
    Event Type
    Death
    Date Received
    April 17, 2008
    Date of Event
    January 25, 2008
    Report Date
    April 16, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD EXCESSIVE BLEEDING FROM A CANNULATION SITE FOR EXTRACORPORAL MEMBRANE OXYGENATION (ECMO). THE SITE WAS IN THE RIGHT NECK AT THE INSERTION INTO THE INTERNAL JUGULAR VEIN. THERE WAS BLEEDING FROM THE INSERTION SITE AND FLOSEAL MATRIX HAEMOSTATIC SEALANT (TOPICAL THROMBIN) WAS INJECTED INTO THE TRACT TO TRY AND PROMOTE THROMBOSIS. THE FLOSEAL THAT WAS INJECTED EMBOLIZED TO THE LUNGS. THE PT BECAME HEMODYNAMICALLY UNSTABLE,AND DESPITE RESUSCITATIVE MEASURES, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL MATRIX HAEMOSTATIC SEALANT FLOSEAL MATRIX HAEMOSTATIC SEALANT - TOPICAL THROMBIN LMF BAXTER HEALTHCARE CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death