BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRESENIUS "H"

    MDR report key: 689420 · Received April 8, 2005

    Report

    Report Number
    689420
    Event Type
    Death
    Date Received
    April 8, 2005
    Date of Event
    March 26, 2005
    Report Date
    April 8, 2005
    Manufacturer
    FRESENIUS MED USA, INC.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNRESPONSIVE WITH DECREASED BLOOD PRESSURE, APHEA. CPR INITIATED, 911 CALLED. MAINTAINED DECREASED BLOOD PRESSURE AND PULSE. REQUIRED ASSISTED BREATHING VIA AMBU AND CPR. TRANSFERRED TO HOSP VIA 911.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESENIUS "H" DIALYSIS MACHINE FII FRESENIUS MED USA, INC. 700811 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death