BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDCOMP

    MDR report key: 154668 · Received March 5, 1998

    Report

    Report Number
    154668
    Event Type
    Death
    Date Received
    March 5, 1998
    Date of Event
    December 1, 1997
    Report Date
    March 5, 1998
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FEMALE PT UNDERWENT PLACEMENT OF RIGHT INTERNAL JUGULAR DOUBLE LUMEN HEMODIALYSIS CATHETER ON 12/1/97. ON 12/2/97 CATHETER WAS FOUND TO BE NOT FUNCTIONING AND THEREFORE WAS CHANGED OVER TO A GUIDE WIRE BY A PHYSICIAN. IMMEDIATELY POST-CHANGE PT EXPRESSED SENSATIONS OF HYPOGLYCEMIA THEN ARRESTED, CPR ADMINISTERED, BUT PT EXPIRED. AUTOPSY REVEALED ATRIAL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCOMP Implant CATHETER MSD MEDCOMP MCDLT1181J UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death