BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3870385 · Received June 2, 2014

    Report

    Report Number
    3003464075-2014-00010
    Event Type
    Death
    Date Received
    June 2, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 1, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROBLEMS WERE FOUND DURING THE INITIAL INVESTIGATION OF THE RETURNED CYCLER. A SUCCESSFUL PRIME AND ALARMS TEST WAS PERFORMED WITH NO ISSUES IDENTIFIED. THERE IS NO EVIDENCE THAT NXSTAGE DEVICE OR THERAPY CONTRIBUTED TO PT'S DEATH. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE HOME TRAINING NURSE REPORTED THE PT DIED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE PT WAS FOUND UNCONSCIOUS BY HER HUSBAND WHO STATED THAT IT WAS A NORMAL RUN, NO SYMPTOMS EXPERIENCED, SHE FELT FINE AND VITALS WERE NORMAL. THE PT WAS SCHEDULED TO SEE A SURGEON TO EVALUATE SMALL AORTIC ANEURYSM. AN AUTOPSY WILL NOT BE PERFORMED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322054 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYS KDI NXSTAGE MEDICAL, INC. CYC-D2E

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death