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

Model Number CAR-124-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); High Blood Pressure/ Hypertension (1908); Pain (1994); Vomiting (2144)

Event Date 08/18/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 298958978
• Report Number: 3003464075-2022-00044
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR124C0
• UDI-Public: +M535CAR124C0/$$102311177040V
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 16 YR
• Patient Sex: Male