BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3896248 · Received June 16, 2014

    Report

    Report Number
    3003464075-2014-00013
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE PATIENT'S SYMPTOMS CANNOT BE DETERMINED. THE DEVICE WAS NOT RETURNED AS REQUESTED AND THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, NO INVESTIGATION CAN BE PERFORMED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE HOME TRAINING NURSE REPORTED A PATIENT WITH A PAST MEDICAL HISTORY OF END STAGE RENAL DISEASE WAS ADMITTED TO THE HOSPITAL FOR MUSCLE WEAKNESS, BONE PAIN, AND BURNING IN FEET, HANDS AND LIPS. ACCORDING TO THE NURSE THE PATIENT HAD IMPAIRED IRON ABSORPTION AND WAS STRUGGLING TO INCREASE HIS HEMOGLOBIN AND IRON PANEL. THE PATIENT WAS RELEASED THE FOLLOWING DAY AND HAS RETURNED TO HOME HEMODIALYSIS TREATMENTS. THE PATIENT'S SYMPTOMS ARE ONGOING BUT LESSENING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353444 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYS KDI NXSTAGE MEDICAL, INC. SAK-301 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization