BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 14516267 · Received May 26, 2022

    Report

    Report Number
    3003464075-2022-00021
    Event Type
    Death
    Date Received
    May 26, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 26, 2022
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K122051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION AND SUCCESSFULLY PASSED TESTING. ALL DEVICES MUST MEET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED WHICH CONFIRMED THAT THE DEVICE MET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. AVAILABLE LOG FILES WERE RETRIEVED AND ANALYZED WHICH SHOWED DEVICE PERFORMANCE WAS WITHOUT DEFICIENCY AND WAS UNREMARKABLE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION FROM THE AVAILABLE INFORMATION. UDI: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON 05 MAY 2022 FROM THE HOME THERAPY NURSE (HTN) OF A (B)(6)-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT ¿CODED¿ APPROXIMATELY ONE HOUR INTO A HEMODIALYSIS TREATMENT ON (B)(6) 2022. EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED AND THE PATIENT WAS TRANSPORTED TO HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED ON 11 MAY 2022 FROM THE HTN STATING THE PATIENT DID NOT RECOVER AND EXPIRED ON (B)(6) 2022. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802810 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-3

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Death