BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 19808310 · Received July 23, 2024

    Report

    Report Number
    3003464075-2024-00236
    Event Type
    Death
    Date Received
    July 23, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 23, 2024
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K170469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. 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. THE NXSTAGE SYSTEM ONE USER GUIDE OUTLINES RISKS ASSOCIATED WITH PERFORMING HEMODIALYSIS THERAPY AND WARNS ALL TREATMENTS MUST BE ADMINISTERED UNDER A PHYSICIAN'S PRESCRIPTION AND MUST BE PERFORMED BY A TRAINED AND QUALIFIED PERSON, CONSIDERED TO BE COMPETENT IN THE USE OF THIS DEVICE BY THE PRESCRIBING PHYSICIAN. THE NXSTAGE SYSTEM ONE USER GUIDE SUPPLEMENT FOR SOLO HOME HEMODIALYSIS OUTLINES RISKS, WARNINGS, AND REQUIREMENTS FOR THE SOLO HOME HEMODIALYSIS PATIENT. (B)(6).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON 01 JUL 2024 FROM THE HOME THERAPY NURSE (HTN) OF A 55-YEAR-OLD MALE PATIENT APPROVED FOR PERFORMING SOLO HEMODIALYSIS WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPIRED DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 01 JUL 2024 FROM THE (HTN) WHO STATED THE PATIENT COMPLETED APPROXIMATELY 3 HRS OF A 3.5 HR TREATMENT, WITH NO RINSEBACK PERFORMED AND WAS FOUND DECEASED SEVERAL HOURS AFTER THE LAST VITAL SIGNS WERE CAPTURED ON (B)(6) 2024. NO FURTHER DETAILS AND NO CAUSE OF DEATH WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936166 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-16

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death