NXSTAGE SYSTEM ONE
Received Jul 20, 2026 · Event occurred Jul 6, 2026
Report 3003464075-2026-00061 · MDR key 25873772
Device
Generic name
High Permeability Hemodialysis System
Manufacturer
Nxstage Medical, Inc.Model number
CAR-170-ECatalog number
CAR-170-E
Lot number
60277097
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
28 YR · Female
- Hypersensitivity/Allergic reaction
- Tachycardia
- Swelling/ Edema
Narrative
Description of Event or Problem
A REPORT WAS RECEIVED ON 06 JUL 2026 FROM THE NURSE OF A 28-YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED AN ALLERGIC REACTION (NOS) DURING HER FIRST HEMODIALYSIS TREATMENT ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 08 JUL 2026 FROM THE NURSE WHO STATED APPROXIMATELY THIRTY SECONDS INTO TREATMENT THE PATIENT BECAME ITCHY; FACE BECAME SWOLLEN AND HEART RATE INCREASED. TREATMENT WAS TERMINATED; 50MG INTRAVENOUS DIPHENHYDRAMINE (BENADRYL) AND OXYGEN WAS ADMINISTERED. EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED AND THE PATIENT WAS TRANSPORTED TO HOSPITAL WHERE SHE WAS OBSERVED AND RELEASED SAME DAY. FOLLOWING THE EVENT, THERAPY WITH THE DEVICE HAS BEEN DISCONTINUED.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER AND CONFIRMED THE PRODUCT WAS RELEASED FOR DISTRIBUTION HAVING MET QUALITY AND MANUFACTURING SPECIFICATIONS AND REQUIREMENTS. THE EVENT IS CONSISTENT WITH A HYPERSENSITIVITY TYPE REACTION. HYPERSENSITIVITY OR ALLERGIC ADVERSE REACTIONS ARE KNOWN RISKS OF HEMODIALYSIS. THE NXSTAGE USER GUIDE AND INSTRUCTIONS FOR USE INCLUDE ALLERGIC REACTION AS A POTENTIAL RISK ASSOCIATED WITH DIALYSIS THERAPY AND ALSO INCLUDE WARNINGS TO MONITOR FOR POTENTIAL ALLERGIC REACTIONS. BIOCOMPATIBILITY OF THE DEVICE HAS BEEN ESTABLISHED. UDI: (B)(4).