BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 4957811 · Received July 31, 2015

    Report

    Report Number
    3003464075-2015-00015
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 5, 2015
    Report Date
    July 7, 2015
    Manufacturer
    NXSTAGE MEDICAL, INC
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH REQUESTED, THE CYCLER HAS NOT BEEN RETURNED BY THE REPORTER FOR INVESTIGATION. SHOULD THE CYCLER BECOME AVAILABLE FOR INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) MALE PATIENT REPORTED TO HIS HOME THERAPY NURSE THAT HE HAD NOT BEEN FEELING WELL. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 AND WAS DIALYZED USING ANOTHER MANUFACTURES HEMODIALYSIS SYSTEM. THE PATIENT WAS DISCHARGED ON THE AFTERNOON OF (B)(6) 2015. THE HCP ASSESSED THE EVENT AS POSSIBLY RELATED TO THE NXSTAGE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499427 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC NX1000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization