NXSTAGE SYSTEM ONE
Received May 5, 2023 · Event occurred Apr 4, 2023
Report 3003464075-2023-00039 · MDR key 16875877
Device
Generic name
High Permeability Hemodialysis System
Manufacturer
Nxstage Medical, Inc.Model number
SAK-404Catalog number
SAK-404
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
44 YR · Male
- Arrhythmia
- Dizziness
- Discomfort
- Numbness
- Hyperkalemia
- Arrhythmia
- Dizziness
- Discomfort
- Numbness
- Hyperkalemia
Narrative
Description of Event or Problem
A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE HOME THERAPY NURSE (HTN) OF A 44 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED NUMBNESS ON THEIR LEFT SIDE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE HTN WHO STATED THE PATIENT ALSO EXPERIENCED DIZZINESS, PRESSURE IN THEIR CHEST, PALPITATIONS, AND FELT UNWELL (NOS). TREATMENT WAS TERMINATED WITH RINSEBACK AND THE PATIENT PRESENTED TO THE HOSPITAL WITH HYPERKALEMIA (NOS) AND WAS ADMITTED FOR OBSERVATION AND TESTING. THE PATIENT RECEIVED HEMODIALYSIS TREATMENT WITH NO ADDITIONAL MEDICAL INTERVENTION BEING REQUIRED AND WAS DISCHARGED (B)(6) 2023. FOLLOWING THE EVENT THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND RESUMED TREATMENT WITH THE NXSTAGE SYSTEM.
Additional Manufacturer Narrative
THE SAK WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION. 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 THAT TREATMENT SHOULD ONLY BE PERFORMED BY A TRAINED AND QUALIFIED PERSON WHO MUST RESPOND PROMPTLY TO HARMFUL CONDITIONS DURING TREATMENT.