BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 21126726 · Received January 10, 2025

    Report

    Report Number
    3003464075-2025-00025
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 10, 2025
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    PMA / PMN Number
    K111174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 DEVICE MEETS REQUIREMENTS FOR ELECTRICAL AND SAFETY STANDARDS AS OUTLINED IN THE USER GUIDE. PER THE USER GUIDE, PROPER ELECTRICAL HOOKUP IN FULL COMPLIANCE WITH ALL APPLICABLE CODES AND DEVICE SPECIFICATIONS MUST BE MAINTAINED. UDI: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON 18 DEC 2024 FROM A 37 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED THE PURE FLOW SYSTEM CAUGHT FIRE AFTER A CARTRIDGE FLUID LEAK DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 19 DEC 2024 FROM THE HOME THERAPY NURSE (HTN) WHO CONFIRMED THERE WAS NO ADVERSE IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478758 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. NX2000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other