MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; HIGH PERMEABILITY HEMODIALYSIS SYSTEM

Model Number	CAR-125-B
Health Effect - Clinical Codes	Anemia (1706); Asthma (1726); High Blood Pressure/ Hypertension (1908); Seizures (2063); Thrombosis (2100)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cartridge was received for evaluation and passed all testing with no trouble found.The involved dialyzer is from a different manufacturer and was not evaluated by nxstage.The device history record for the product was reviewed which confirmed the cartridge was released meeting all quality and manufacturing requirements.Biocompatibility has been established.
Event or Problem Description
A report was received on 8 oct 2019 from the home therapy nurse (htn), regarding an (b)(6) male with multiple comorbidities including asthma, inferior vena cava thrombosis, clotting disorder, anemia, hypertension, seizures, polycystic kidney and transplant failure who had pink-tinged effluent that tested negative for blood during standard home hemodialysis therapy on (b)(6) 2019.Per the htn treatment was terminated and the patient was taken to hospital by the caregiver for precautionary observation.Additional information was received 08 oct 2019 - 30 oct 2019 from the htn which revealed the patient was admitted to hospital from (b)(6) 2019 for blood tests and cultures (nos) which were unremarkable.The patient did not experience symptoms and received dialysis while hospitalized with no additional events reported.

• Brand Name: NXSTAGE SYSTEM ONE
• Common Device Name: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 9268126
• Report Number: 3003464075-2019-00058
• Device Sequence Number: 127709
• Product Code: KDI
• UDI-Device Identifier: M535CAR125B0
• UDI-Public: +M535CAR125B0/$$0121902770482
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/01/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/20/2021
• Device Model Number: CAR-125-B
• Device Catalogue Number: CAR-125-B
• Device Lot Number: 90277048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 8 YR
• Patient Weight: 24
• Date Report Sent to FDA: 01/01/2005