BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUAL LUMEN CATHETER

    MDR report key: 17368 · Received September 23, 1994

    Report

    Report Number
    17368
    Event Type
    Death
    Date Received
    September 23, 1994
    Date of Event
    September 13, 1994
    Report Date
    September 23, 1994
    Manufacturer
    CARDIO MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A PREVIOUS RIGHT SUBCLAVIAN CATHETER BUT IT WAS CAUSING SOME SWELLING OF HER ARM AND POSSIBLE DEEP VENOUS THROMBOSIS OF THE SUBCLAVIAN VEIN. NEPHROLOGIST REQUESTED A RIGHT INTERNAL JUGULAR CATH BE INSERTED INSTEAD. SURGERY WAS STARTED AT 10:24 AM. AFTER CATH WAS INTRODUCED IN THE SUPERIOR VENA CAVA IT APPEARED TO BE IN GOOD POSITION PER SURGEON; HOWEVER THE FLUID WAS QUITE THIN LIKE A SSEROSANGUINOU LIQUID. AT THAT TIME IT WAS FELT CATHETER WAS NOT IN CORRECT LUMEN OF THE VEIN. THE CATHETER WAS WITHDRAWN. A SECOND ATTEMPT AT INSERTION WAS MADE WITH ANOTHER NEW CATHETER. AGAIN, THE CATHETER'S BLOOD RETURN WAS SEROSANGUINOUS INSTEAD OF BLOODY. A SMALL AMOUNT OF DYE WAS INGESTED THROUGH CATHETER; IT WAS SEEN TO EXTRAVASATE TO THE RIGHT PLEURAL CAVITY. THE CATHETER WAS THEN REMOVED. THE ANESTHESIOLOGIST THEN NOTICED THAT PT'S BLOOD PRESSURE DROPPED TO ABOUT 50 SYSTOLIC. FLUID RESUSCITATION WAS STARTED AND EPINEPHRINE WAS GIVEN. CONSENT WAS OBTAINED FROM FAMILY TO INSERT CHEST TUBE. APPROX 300 CC'S OF BLOOD WERE EVACUATED FROM CHEST TUBE. BECAUSE OF PREVIOUS NO CODE REQUEST, ONLY SUPPORTIVE CARE WAS GIVEN TO PT. THE BLOOD PRESSURE REMAINED LOW. THERE DID NOT APPEAR TO BE ANY SIGNIFICANT HEMOSTASIS FROM THE RE-EXPANSION OF THE LUNG BY THE CHEST TUBE, POSSIBLY BECAUSE OF THE PT'S THROMBOCYTOPENIA. THE PRESSURE CONTINUED TO BE LOW; THE PT BECAME PULSELESS AND WAS FINALLY PRONOUNCED DEED AT 11:58 AM. THE CORONER'S OFFICE WAS NOTIFIED AND DID NOT RELEASE THE BODY. THE INVOLVED CATHETERS WERE DISCARDED/LOST IN THE SURGICAL WASTE CONTAINERS AND COULD NOT BE LOCATED WITH A LATER SEARCH. THE MFR'S SALES REP WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL LUMEN CATHETER DUAL LUMEN CATHETER DQO CARDIO MEDICAL PRODUCTS, INC. 449-313, 327-648

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death