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

Model Number NX1000-3

Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017)

Patient Problem Exsanguination (1841)

Event Date 10/04/2021

Event Type  Death  

Manufacturer Narrative

The involved device was not received for evaluation.A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.Based on the available information, there is no indication that a malfunction occurred.The nxstage system one user guide outlines risks associated with performing hemodialysis therapy and warns that treatment should only be performed by a trained and qualified person who must respond promptly to harmful conditions during treatment.The nxstage system one user guide supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient.(b)(4).

Event Description

A report was received on (b)(6) 2021 from the home therapy nurse (htn) of a (b)(6) male patient with a medical history including multiple comorbidities and end stage renal disease, approved for performing solo home hemodialysis therapy, stating that the patient disconnected and went to the bathroom during a hemodialysis treatment on (b)(6) 2021.The patient was later found expired at an unspecified time.Additional information was received on 06-27 oct 2021 from the htn stating that proper disconnection from the device was not performed when the patient stopped treatment.Per the htn, the cause of death documented by the physician was exsanguination from the patients vascular access, unrelated to the device.

• 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: 12706014
• MDR Text Key: 278630928
• Report Number: 3003464075-2021-00058
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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): Death
• Patient Age: 44 YR
• Patient Weight: 127