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

Model Number	CAR-170-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Discomfort (2330); Shaking/Tremors (2515); Syncope/Fainting (4411)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received on 21 jun 2024 from the caregiver of a 78 year old female patient with a medical history including anaphylactic shock and end stage renal disease, who stated the patient experienced low blood pressure (nos) and became unresponsive during initiation of her first hemodialysis treatment with the device on (b)(6) 2024.The patient was transported to hospital on (b)(6) 2024.Additional information was received on 27 jun 2024 from the home therapy nurse (htn) stating rinseback was performed, oxygen was given, and intravenous saline was administered.Additional symptoms included vomiting, tremors, generalized pressure in the chest, back, neck and throat and altered sensation in the lower extremities.The patient was observed in the emergency department at the hospital and released with no additional medical intervention reported on (b)(6) 2024.Per the htn, the patient has resumed therapy with a dialyzer from a different manufacturer.
Additional Manufacturer Narrative
Allergic or adverse reactions are known risks of hemodialysis.The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions.Biocompatibility of the device has been established.

• 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: 19665745
• Report Number: 3003464075-2024-00229
• Device Sequence Number: 6914174
• Product Code: KDI
• UDI-Device Identifier: M535CAR170C0
• UDI-Public: +M535CAR170C0/$$032530977059C
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 03/01/2025
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 30977059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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: 78 YR
• Patient Sex: Female