BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 22953247 · Received September 3, 2025

    Report

    Report Number
    3003464075-2025-00098
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    July 26, 2025
    Report Date
    September 3, 2025
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    PMA / PMN Number
    K111174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALL DEVICES MUST MEET QUALITY REQUIREMENTS 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. UDI: (B)(4).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON 16 AUG 2025 FROM A 60-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING GOUT, HYPERTENSION AND END STAGE RENAL DISEASE, WHO STATED HE WAS COLD AND DIZZY DURING A HOME HEMODIALYSIS AND WENT TO HOSPITAL ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 26 AUG 2025 FROM THE NURSE WHO STATED THE PATIENT WAS EVALUATED ON (B)(6) 2025 WHERE HE WAS ADMINISTERED 500ML OF SALINE AND INTRAVENOUS ANTIBIOTICS (VANCOMYCIN AND ZOSYN), DOSES NOT SPECIFIED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION SAME DAY AND HAS RESUMED THERAPY WITH NXSTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734895 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. NX2000-2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| H