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

Model Number	CAR-172-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Hemolysis (1886); High Blood Pressure/ Hypertension (1908); Hematuria (2558)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received on 13 feb 2025 from the nurse of a 48-year-old female patient with a medical history including end stage renal disease, who stated blood was observed in the waste line during a hemodialysis treatment on (b)(6) 2025.The patient went to the emergency room and was diagnosed with hemolysis.Additional information was received on 24 feb 2025 from the home therapy nurse (htn), who stated the patient experienced blood in her urine, chest pain and hypertension.Per the htn, the patient was admitted to the hospital on (b)(6) 2025 and discharged in stable condition on (b)(6) 2025.Following the event, the patient has recovered without sequalae and resumed treatment with the nxstage system.
Additional Manufacturer Narrative
The cartridge was evaluated and no related issues found with the bloodline.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 nxstage system one user guide includes hemolysis as a potential risk associated with dialysis therapy and states an underlying medical condition or medication may alter the normal effluent appearance.All treatments must be administered under a physician's prescription and performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician so that alarms and harmful conditions can be responded to promptly.

• Brand Name: NXSTAGE SYSTEM ONE
• Common Device Name: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• Manufacturer (Section G): MEDIMEXICO S. DE R. L. DE C. V; av. valle imperial no. 10523; parque industrial valle sur; tijuana 22180 ; MX 22180
• Manufacturer Contact: paula rogalski ; nxstage medical, inc.; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 21561293
• Report Number: 3003464075-2025-00051
• Device Sequence Number: 19927017
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$0526411770287
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 41177028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female