BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMODILUTION VENOUS INFUSION PORT CATHETER

    MDR report key: 12233 · Received February 14, 1994

    Report

    Report Number
    12233
    Event Type
    Death
    Date Received
    February 14, 1994
    Date of Event
    February 2, 1994
    Report Date
    February 14, 1994
    Manufacturer
    EDWARDS CVS DIV. BAXTER HEALTHCARE CORP.
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS STATUS POST ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR ON 1/28/94, WITH PERIOPERATIVE MYOCARDIAL INFARCTION. THOUGH HIS CONDITION INITIALLY STABILIZED, HE EXPERIENCED ARRHYTHMIA AND DETERIORATING VITALS ON 2/1/94. A CATHETER PLACED DURING THE AAA REPAIR WAS REPLACED AT APPROX 11 PM ON 2/1/94. ON THE AFTERNOON OF 2/2/94, THE CATHETER SPONTANEOUSLY WEDGED. A PHYSICIAN DEFLATED THE BALLOON AND PULLED THE CATHETER BACK UNTIL A GOOD PULMONARY ARTERY WAVE FORM WAS OBTAINED. THE CATHETER WAS WEDGED ONCE TO ASSURE PROPER POSITIONING AND A WEDGE TRACING WAS OBTAINED. THE BALLOON WAS DEFLATED AND A GOOD PULMONARY ARTERY WAVE FORM APPEARED. BLOOD WAS THEN OBSERVED IN THE ENDOTRACHEAL TUBE. THE PT'S CONDITION DETERIORATED, A CODE WAS CALLED. THE CODE WAS UNSUCCESSFUL AND THE PT DIED. AUTOPSY STATED THE CAUSE OF DEATH TO BE PULMONARY HEMORRHAGE. NO PERFORATION WAS IDENTIFIED, AND IT COULD NOT BE CONCLUSIVELY DETERMINED IF THE HEMORRHAGE WAS DUE TO PULMONARY EMBOLISM OR INFARCTION, OR PULMONARY ARTERY CATHETER EROSION. NO MALFUNCTION OF THE DEVICE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMODILUTION VENOUS INFUSION PORT CATHETER Implant SWAN GANZ CATHETER DYG EDWARDS CVS DIV. BAXTER HEALTHCARE CORP. 93A831H 7.5 FRENCH

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death