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

Model Number NX1000-3

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

Patient Problem Insufficient Information (4580)

Event Date 10/10/2021

Event Type  Death  

Manufacturer Narrative

There was no device malfunction.The device was received for evaluation and successfully passed testing, confirming proper functionality of the device and sensors.Available log files were retrieved and analyzed which showed the device was performing as designed and intended.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 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.Udi:(b)(6).

Event Description

A report was received on 12 oct 2021 from the home therapy nurse (htn) of a (b)(6) male with a medical history including diabetes and end stage renal disease, who stated the patient expired at an unspecified time during a home hemodialysis treatment on (b)(6) 2021.Additional information was received on 13 oct 2021 from the htn who stated the patient treated for approximately 3 hours before being found by a family member and 911 was called.Although requested, a cause of death was not provided.

• 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: 12750797
• MDR Text Key: 280086425
• Report Number: 3003464075-2021-00065
• 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: 11/04/2021

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: Lay User/Patient
• Device Model Number: NX1000-3
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2020
• 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: 61 YR
• Patient Weight: 122