NXSTAGE SYSTEM ONE

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED WHICH CONFIRMED THAT THE PRODUCT MET ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THERE IS NO INFORMATION TO INDICATE THAT A MALFUNCTION OCCURRED, SUPPORTED BY THE DEVICE TESTING PERFORMED BY THE FACILITY. ALLERGIC OR 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. MDR REPORT#: MW5115559.

Description of Event or Problem

A REPORT WAS RECEIVED ON 20 MAR 2023 FROM THE NURSE OF A 70-YEAR-OLD MALE PATIENT WITH MULTIPLE COMORBIDITIES AND END STAGE RENAL DISEASE, STATING THE PATIENT FELT ITCHY APPROXIMATELY ONE MINUTE INTO HIS FIRST HEMODIALYSIS TREATMENT WITH THE DEVICE ON (B)(6)2023, FOLLOWED TWO MINUTES LATER BY HYPOTENSION. TREATMENT WAS TERMINATED AND THE PATIENT DEVELOPED HIVES AND REPORTED FEELING DIZZY. 500 ML SALINE WAS ADMINISTRATED, THE PATIENT'S BLOOD PRESSURE STABILIZED AND THE DIZZINESS AND HIVES RESOLVED WITHOUT FURTHER INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 23 MAR 2023 FROM THE NURSE WHO STATED THE PATIENT RECOVERED WITHOUT SEQUELAE. POST-INCIDENT LAB SPECIMENS WERE COLLECTED FROM THE DIALYSIS PURIFICATION SYSTEM AND ALL LAB RESULTS WERE IN ACCEPTABLE RANGES FOR ELECTROLYTES, COLONY COUNT AND ENDOTOXIN. THE PATIENT CHANGED TO A DIFFERENT MANUFACTURER FOR HEMODIALYSIS THERAPY.