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

Model Number	CAR-535
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received on 15 dec 2023 from the nurse of a 50 year old male critical care patient, who stated a cartridge blood leak was observed during a hemodialysis treatment on (b)(6) 2023.Additional information was received on 20 dec 2023 from the nurse who stated there was no medical intervention required.The cartridge was replaced and the patient resumed therapy with the nxstage system later that day.
Additional Manufacturer Narrative
A photo was provided which confirmed the presence of blood outside the extracorporeal circuit.All devices must meet quality requirements and manufacturing specifications prior to release.The instructions for use states "check the system for blood and fluid leaks during treatment, and pay close attention to the blood line and access connections." 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: 18442800
• Report Number: 3003464075-2024-00003
• Device Sequence Number: 6818135
• Product Code: KDI
• UDI-Device Identifier: M535CAR5350
• UDI-Public: +M535CAR5350/$$032530978013$
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K183158
• 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): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2025
• Device Model Number: CAR-535
• Device Catalogue Number: CAR-535
• Device Lot Number: 30978013
• 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: Not provided
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2023
• 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: Other
• Patient Age: 50 YR
• Patient Sex: Male