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

Model Number	CAR-124-C
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The involved cartridge was not received for evaluation.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.
Event or Problem Description
A report was received on 11 dec 2025 from a health care professional (hcp), regarding a 38 year old female patient, stating the patient experienced acute intravascular hemolysis and was transported by emergency medical services (ems) to hospital, date unspecified.Additional information was received on 19 dec 2025 from the hcp who stated the patient was hospitalized for 72 hours and was discharged to resume therapy with a different cartridge.

• 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: 23975939
• Report Number: 3003464075-2026-00001
• Device Sequence Number: 13417126
• Product Code: KDI
• UDI-Device Identifier: M535CAR124C0
• UDI-Public: +M535CAR124C0/$$012750277104/
• Combination Product (Y/N): N
• PMA/510(K) Number: K050525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: Lay User/Patient
• Device Model Number: CAR-124-C
• Device Catalogue Number: CAR-124-C
• Device Lot Number: 50277104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• 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: 38 YR
• Patient Sex: Female