BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW DOUBLE LUMEN

    MDR report key: 15257 · Received January 24, 1994

    Report

    Report Number
    1036499-1993-00025
    Event Type
    Death
    Date Received
    January 24, 1994
    Date of Event
    October 24, 1993
    Report Date
    November 18, 1993
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    FEG
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WAS INFORMED OF AN INCIDENT THAT OCCURRED THREE WEEKS AGO. PT PRESENTED IN THE E.R. WITH GUNSHOT WOUND IN L EPIGASTRICARES. SEVEN FRENCH DOUBLE LUMEN WAS PLACED IN E.R. VIA RIGHT INTERNAL JUGULAR. PT WAS TAKEN TO O.R. APPROX. TWO HRS AFTER THE LINE WAS PLACED ANOTHER X-RAY WAS TAKEN (WHILE IN E.R. A CHEST FILM WAS SHOT AND NO PLEURAL EFFUSION WAS EVIDENT AT THAT TIME)WHICH SHOWED A PLEURAL EFFUSION WHILE DOING AN X-RAY FOR TIP PLACEMENT. ON DAY FOUR, POST OP[, THE PT DEMONSTRATED PROBLEMS WHICH REQUIRES EMERGENCY RESUSCITATION. THE PT. DID NOT MAKE IT. DR INFORMED ME OF THIS SINCE THE POST AUTOPSY SAID THE PT EXPIRED O/R OTHER COMPLICATIONS.THE AUTOPSY SHOWED A TEAR IN THE VESSEL OF THE SUPERIOR VENA CAVA AND RIGHT INNOMINATE REGION THAT WAS A TEAR FROM BOTTOM TO TOP THAT POSSIBILITY RELATED TO PRODUCT. WHEN ASKED IF THEIR RISK MANAGEMENT PERSON HAD BEEN NOTIFIED THE RSPONSE WAS YES BUT NO ACTION WAS BEING TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW DOUBLE LUMEN CATHETER FEG ARROW INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death