BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 14287385 · Received May 5, 2022

    Report

    Report Number
    3003464075-2022-00014
    Event Type
    Death
    Date Received
    May 5, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 4, 2022
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K170469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. THE NXSTAGE SYSTEM ONE USER GUIDE SUPPLEMENT FOR SOLO HOME HEMODIALYSIS OUTLINES RISKS, WARNINGS, AND REQUIREMENTS FOR THE SOLO HOME HEMODIALYSIS PATIENT. UDI: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON (B)(6) 2022 FROM THE HOME THERAPY NURSE (HTN) OF A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY INCLUDING MULTIPLE COMORBIDITIES AND END STAGE KIDNEY DISEASE, APPROVED FOR PERFORMING SOLO HOME HEMODIALYSIS THERAPY, WHO STATED THE PATIENT WAS FOUND EXPIRED ON (B)(6) 2022 FOLLOWING A HEMODIALYSIS TREATMENT ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022 FROM THE HOME THERAPY NURSE (HTN) STATING THAT A CAUSE OF DEATH HAS NOT BEEN DETERMINED YET THE PHYSICIAN STATES THAT IT IS BEING CONSIDERED A NEUROLOGIC EVENT NOT RELATED TO THE NXSTAGE PRODUCT OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046215 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-16-A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death