BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 23850524 · Received December 19, 2025

    Report

    Report Number
    3003464075-2025-00137
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 30, 2025
    Report Date
    April 17, 2026
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    PMA / PMN Number
    K111174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION, AND THE REPORTED ALARM CONDITION WAS DUPLICATED. THE NXSTAGE PUREFLOW SL (PFSL) IS AN OPTIONAL ACCESSORY TO THE NXSTAGE CYCLER THAT PREPARES DIALYSATE FOR USE DURING HEMODIALYSIS AS PRESCRIBED BY THE PHYSICIAN. PATIENTS ARE INSTRUCTED TO CONTACT THEIR DIALYSIS CENTER WHO CAN IDENTIFY A PLAN FOR TIMELY EMERGENCY BACKUP DIALYSIS IF ISSUES WITH SUPPLIES OR EQUIPMENT PREVENT COMPLETION OF TREATMENT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON 02 DEC 2025 FROM THE CAREGIVER OF A 69-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING MULTIPLE COMORBIDITIES AND END STAGE RENAL DISEASE, WHO REQUIRED ASSISTANCE TROUBLESHOOTING ALARMS AND MISSED SEVERAL HOME HEMODIALYSIS TREATMENTS. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 08 DEC 2025 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT'S LAST SUCCESSFUL HOME HEMODIALYSIS TREATMENT WAS (B)(6) 2025. THE PATIENT WAS IN HOSPITAL FROM (B)(6) 2025 UNTIL 05 DEC 2025. UPON DISCHARGE, THE PATIENT HAS RESUMED THERAPY WITH NXSTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260040 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. NX2000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| H