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

Model Number	CAR-124-C
Health Effect - Clinical Codes	Hemolysis (1886); High Blood Pressure/ Hypertension (1908); Pain (1994); Vomiting (2144); Hyperkalemia (4824)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received on (b)(6) 2022 from the nurse of a 16 year old male patient with a medical history including nephronophthisis and end stage renal disease, who stated the patient showed signs of hemolysis (nos) and experienced back pain approximately two hours into an in-center hemodialysis treatment on (b)(6) 2022.Per the nurse, the patient "appears to be fine" but will be kept at the hospital overnight to be observed.Additional information was received on 23 and 25 aug 2022 from the nurse who confirmed the patient was observed overnight, and experienced additional symptoms of increased potassium 6 meq/l, increased blood pressure (nos) and vomiting, all resolved without medical intervention.Per the nurse, patient was released on the evening of (b)(6) 2022 and will resume therapy with nxstage.
Additional Manufacturer Narrative
The cartridge was not received for evaluation, photo review was unable to confirm a malfunction.A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.The system one user guide and cartridge instructions for use (ifu) state not to use a cartridge with kinked blood lines and to always inspect the blood lines for kinks before and during use.

• 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
• MDR Report Key: 15326565
• Report Number: 3003464075-2022-00044
• Device Sequence Number: 6484413
• Product Code: KDI
• UDI-Device Identifier: M535CAR124C0
• UDI-Public: +M535CAR124C0/$$102311177040V
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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: 10/16/2023
• Device Model Number: CAR-124-C
• Device Catalogue Number: CAR-124-C
• Device Lot Number: 11177040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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: 16 YR
• Patient Sex: Male