BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1739269 · Received June 25, 2010

    Report

    Report Number
    3003464075-2010-00061
    Event Type
    Death
    Date Received
    June 25, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 28, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. NO PROBLEM FOUND WITH RETURNED CYCLER. CARTRIDGE DISCARDED AND NOT AVAILABLE FOR INSPECTION. REVIEW OF CYCLER DATA LOGFILE SHOWS THAT THE STOP BUTTON WAS PRESSED 17 MINUTES AFTER THE TREATMENT DIALYSATE AND ULTRAFILTRATION TARGETS WERE REACHED INDICATING THE END OF THE TREATMENT. THE BLOOD PUMP WAS NEVER RESTARTED TO PERFORM AUTOMATED RINSEBACK AND THE CYCLER POWER WAS TURNED OFF ABOUT 8 MINUTES LATER AT APPROXIMATELY 0901 HOURS LOCAL TIME. USER'S GUIDE INCLUDES APPROPRIATE WARNINGS THAT A TRAINED AND QUALIFIED PERSON MUST OBSERVE ALL TREATMENTS AND THAT A PT SHOULD NEVER DIALYZE ALONE. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    HEMODIALYSIS PT FOUND SLUMPED ON THE FLOOR AT APPROXIMATELY 1800 HOURS, UNQUANTIFIED AMOUNT OF BLOOD ON BLANKET. ARTERIAL PT BLOOD LINE ATTACHED TO SALINE BAG FOR RINSEBACK AND LEFT ARM OF PERMACATHETER WAS OPEN. AUTOPSY CITED CAUSE OF DEATH AS EXSANGUINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CYC-D2E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death