NXSTAGE SYSTEM ONE
Received Jul 1, 2026 · Event occurred Jun 15, 2026
Report 3003464075-2026-00055 · MDR key 25679252
Device
Generic name
High Permeability Hemodialysis System
Manufacturer
Nxstage Medical, Inc.Model number
NX2000-1-CANCatalog number
PUREFLOW SL CONTROL UNIT, CANA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
42 YR · Male
- Renal Impairment
Narrative
Description of Event or Problem
A REPORT WAS RECEIVED ON (B)(6) 2026 FROM A 42-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED HE WAS UNABLE TO COMPLETE HEMODIALYSIS TREATMENT ON (B)(6) 2026 AND WAS HOSPITALIZED (B)(6) 2026. ALTHOUGH REQUESTED, NO ADDITIONAL DETAILS OF THE HOSPITALIZATION OR DISCHARGE DATE WERE PROVIDED.
Additional Manufacturer Narrative
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).