BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 488481 · Received September 26, 2003

    Report

    Report Number
    MW1029686
    Event Type
    Death
    Date Received
    September 26, 2003
    Date of Event
    September 2, 2003
    Report Date
    September 26, 2003
    Manufacturer
    FRESENIUS USA
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ON HEMODIALYSIS. NURSE FOUND TUBING DISCONNECTED FROM THE CATHETER, VISUAL ALARMS WERE DISPLAYED, AUDIBLE ALARMS WERE NOT SOUNDING. NURSE CALLED CODE, PT EXPIRED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/31/03: THE USER FACILITY HAS DECIDED NOT TO DISCLOSE ADD'L INFO REGARDING THE INCIDENT. THE ONLY INFO THAT THEY WERE WILLING TO PROVIDE WAS THE STATUS OF THE MACHINE. THE MACHINE WAS RETIRED AFTER 11 YRS OF SERVICE. IT WAS DECIDED THAT IT HAS REACHED THE END OF ITS USEFUL LIFE. THE HOSP BIO-MEDICAL DEPT AND AN OUTSIDE TECH CHECKED THE MACHINE AND IT WAS FOUND TO BE FUNCTIONING PROPERLY. THE ONLY CONCERN THAT WAS RAISED WAS THE ABSENCE OF AN AUDIBLE ALARM WHEN THE VENOUS LINE WAS PULLED OUT OF THE OPTICAL SENSOR. THERE IS A FEATURE/OPTION IN THE FRESENIUS HEMODIALYSIS MACHINE TO SUPPRESS AUDIBLE ALARMS WHEN THERE IS NO BLOOD SENSED (WHEN SALINE IS IN THE LINE OR WHEN THE LINE IS OUT OF THE OPTICAL SENSOR). THE MACHINE IS DESIGNED TO ACTIVATE VISUAL ALARMS AND CAUSE THE BLOOD PUMP TO STOP IN THE PRESENCE OF AN ALARM GENERATING CONDITION, REGARDLESS OF WHETHER THIS FEATURE WAS SELECTED OR NOT. BASED ON THE USER FACILITY REPORT, THERE WERE VISUAL ALARMS BUT NO AUDIBLE ALARM. IT IS POSSIBLE THAT THE LINE WAS OUT OF THE OPTICAL SENSOR DURING THE EVENT, THEREFORE, NO AUDIBLE ALARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE FII FRESENIUS USA 2008E *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death