BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3951924 · Received July 7, 2014

    Report

    Report Number
    3003464075-2014-00017
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 9, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT IS UNDER INVESTIGATION. REQUESTS FOR ADD'L INFO WERE NOT RESPONDED TO. WE WILL CONTINUE ATTEMPTS TO FOLLOW UP AND PROVIDE ADD'L INFO IF IT SHOULD BECOME AVAILABLE. THIS REPORT AND THE INFO CONTAINED HEREIN IS SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION UNDER 21 CFR PART 803 AND REPRESENTS THE INFO AVAILABLE TO THE COMPANY AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    THE HOME TRAINING NURSE REPORTED THE (B)(6) MALE PT EXPERIENCED NEUROLOGICAL ISSUES AND WAS ADMITTED TO THE HOSP. THE PT HAS A PAST HISTORY SIGNIFICANT FOR DIABETES AND HAD BEEN TREATING WITH NXSTAGE SAK-303 SINCE (B)(6) 2013. NO ADD'L INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394895 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYS KDI NXSTAGE MEDICAL, INC. SAK-303 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization