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

Model Number NX1000-3-A

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

Patient Problems Abdominal Pain (1685); Hemolysis (1886); High Blood Pressure/ Hypertension (1908)

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

The involved cycler was not received for evaluation.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.Available log files were retrieved and analyzed which showed device performance was without deficiency and was unremarkable.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.The guide also warns that treatment should only be performed by a trained and qualified person who must respond promptly to harmful conditions during treatment.Udi: (b)(4).

Event Description

A report was received on 05 oct 2022 from the health care professional (hcp) of a 78 year old male patient with a medical history including end stage renal disease, stating hemolysis was observed after a hemodialysis treatment on (b)(6) 2022.Additional information was received on 10 oct 2022 from the hcp who stated the patient experienced abdominal pain and went into hypertensive crisis (nos) during treatment on (b)(6) 2022.Following treatment, the patient received anti-hypertensive medication and presented to hospital for evaluation.Labs revealed hemolysis and the patient was admitted on (b)(6) 2022 for further testing.The patient received hemodialysis and was discharged on (b)(6) 2022 with no report of additional symptoms or medical intervention being required.Following the event the patient has recovered without sequalae.

• 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: 15690321
• MDR Text Key: 302574815
• Report Number: 3003464075-2022-00068
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NX1000-3-A
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER, ROHS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: No
• 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: 78 YR
• Patient Sex: Male