NXSTAGE SYSTEM ONE

Additional Manufacturer Narrative

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 NXSTAGE PUREFLOW USER GUIDE. PER THE NXSTAGE PUREFLOW 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

A REPORT WAS RECEIVED ON 07 NOV 2025 FROM A 63-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED HIS DEVICE SMELLED LIKE SMOKE AND TRIPPED THE CIRCUIT BREAKER AT HIS HOME WHILE MAKING A BATCH OF DIALYSATE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 18 AND 24 NOV 2025 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT OBSERVED SPARKS COMING FROM THE DEVICE IN ADDITION TO A ¿POPPING SOUND¿, AND THE SMELL OF SMOKE. PER THE HTN, NO OPEN FLAME WAS PRESENT AND THERE WAS NO ADVERSE IMPACT TO THE PATIENT WHO CONTINUES TO PERFORM THERAPY WITH NXSTAGE SYSTEM.