BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008H

    MDR report key: 297283 · Received September 21, 2000

    Report

    Report Number
    297283
    Event Type
    Death
    Date Received
    September 21, 2000
    Date of Event
    August 10, 2000
    Report Date
    September 14, 2000
    Manufacturer
    FRESENIUS USA
    Product Code
    FII
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT FOUND UNRESPONSIVE WITH BOTH NEEDLES DISLODGED FROM THIGH GRAFT, POOL OF BLOOD NOTED UNDER PT'S CHAIR. MACHINE NOT ALARMING AND "BFR" AT 330. NURSE TURNED OFF "BFR" IMMEDIATELY. BEVEL OF VENOUS NEEDLE WAS FOUND ON THE FLOOR UNDER THE CHAIR. STAFF BELIEVE ARTERIAL NEEDLE DISLODGEMENT IMMEDIATELY PRECEDED DISCOVERY OF PT BECAUSE STAFF NOTED NO AIR IN THE SYSTEM AT TIME OF DISCOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS 2008H DIALYSIS MACHINE FII FRESENIUS USA 2008H NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death 1. COMBISET BLOOD TUBING SET.| 3. POLYSULFONE HIGH FLUX DIALYZER FEOB| 2. MEDISYSTEMS READY SET FISTULA NEEDLES