BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 506926 · Received January 13, 2004

    Report

    Report Number
    2937457-2004-00003
    Event Type
    Death
    Date Received
    January 13, 2004
    Date of Event
    December 17, 2003
    Report Date
    December 19, 2003
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS FACILITY REPORTED THAT FIVE MINUTES AFTER TREATMENT WAS INITIATED, THE HEMODIALYSIS MACHINE ALARMED. THE NURSE WHO RESPONDED TO THE ALARM IMMEDIATELY CALLED FOR HELP. WHEN THE CHARGE NURSE AND THE CLINIC MANAGER RESPONDED TO THE CALL, THEY FOUND THE VENOUS LINE FILLED WITH AIR AND THE PT WAS UNRESPONSIVE. CPR WAS INITIATED BUT THE PT EXPIRED. CAUSE OF DEATH WAS LISTED AS CARDIAC ARREST. NO AUTOPSY WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE FII FRESENIUS MEDICAL CARE NORTH AMERICA 2008H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death