BEUDAMED
    FDA Adverse Event Death Summary report: N

    TESIO CATHETER

    MDR report key: 276458 · Received May 3, 2000

    Report

    Report Number
    276458
    Event Type
    Death
    Date Received
    May 3, 2000
    Date of Event
    April 28, 2000
    Report Date
    May 2, 2000
    Manufacturer
    MEDCOMP
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER INITIATION OF HEMODIALYSIS, TREATMENT INITIALLY PROCEEDED WELL. ABOUT 15 MINS INTO TREATMENT, THE PT HAD APPROX 300 CC BLOOD LOSS FROM A TESIO CATHETER, AT POINT OF CONNECTION TO DIALYSIS TUBING. PT HAD CARDIOPULMONARY ARREST. WENT INTO V-FIB ON MONITOR. SINCE PT WAS DNR/DNI, NO CPR DONE. CASE REFERRED TO THE MEDICAL EXAMINER. MD FOUND CONNECTION OPEN/LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESIO CATHETER VASCULAR ACCESS FOR HEMODIALYSIS LFJ MEDCOMP 1999109 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| L COMBI SET-HEMODIALYSIS TUBING 8MM PUMP SEGMENT.| DATE OF THERAPY 4-28-00.