NXSTAGE SYSTEM ONE
Received Sep 3, 2025 · Event occurred Jul 26, 2025
Report 3003464075-2025-00098 · MDR key 22953247
Device
Generic name
High Permeability Hemodialysis System
Manufacturer
Nxstage Medical, Inc.Model number
NX2000-2Catalog number
PUREFLOW SL CHASSIS
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
60 YR · Male
- Dizziness
- Alteration in Body Temperature
- Dizziness
- Alteration in Body Temperature
Narrative
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).
Description of Event or Problem
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.