BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2537626 · Received April 5, 2012

    Report

    Report Number
    3003464075-2012-00023
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 10, 2012
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION OCCURRED. FACILITY STAFF REPORT THAT THEY DO NOT BELIEVE THAT THERE IS A PROBLEM WITH THE CYCLER AND HAVE CONTINUED TO USE THE CYCLER WITH NO FURTHER ISSUES. ANALYSIS OF THE TREATMENT LOG FILE INDICATES THE CYCLER RESPONDED APPROPRIATELY WITH MULTIPLE ALARMS INDICATIVE OF CONDITIONS CONSISTENT WITH INADEQUATE VASCULAR ACCESS FLOW AND CLOTTING IN THE VASCULAR ACCESS AND EXTRACORPOREAL BLOOD CIRCUIT. THE USER GUIDE INCLUDES APPROPRIATE PROBABLE CAUSES AND INSTRUCTIONS FOR TROUBLESHOOTING ALARMS. THE USER GUIDE ALSO INCLUDES WARNINGS THAT THE RISK OF CLOTTING INCREASES WHEN THE BLOOD PUMP IS STOPPED AND THAT IN ORDER TO REDUCE THE RISK OF CLOTTING THE OPERATOR SHOULD DISCONTINUE THE TREATMENT IF ALARMS CANNOT BE RESOLVED IN A TIMELY MANNER. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    NURSE REQUESTED REVIEW OF CYCLER DATA LOG FILE FOR A CRRT TREATMENT DURING WHICH A CRITICALLY ILL PATIENT EXPIRED. NURSE REPORTED THE VASCULAR ACCESS BECAME PROBLEMATIC AND MULTIPLE ALARMS OCCURRED ABOUT ONE HOUR AFTER THE START OF THE TREATMENT. PATIENT BECAME HYPOTENSIVE AND HAD PULSELESS ELECTRICAL ACTIVITY (PEA). CODE WAS CALLED AND PATIENT EXPIRED. CAUSE OF PATIENT DEATH UNKNOWN. NO AUTOPSY PERFORMED.

    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 65 YR Death