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

Model Number NX1000-1

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

Patient Problems Dyspnea (1816); Malaise (2359); Loss of consciousness (2418)

Event Date 03/09/2021

Event Type  Death  

Manufacturer Narrative

The device was received for evaluation and successfully passed the testing, confirming proper functionality of the device and sensors. Available log files were retrieved and analyzed which showed device performance was without incident and was unremarkable. A review of the device history record confirmed the product was released meeting all product design specifications and quality criteria. All information supports the device was functioning as designed and intended with no malfunction. Udi: (b)(4).

Event Description

A report was received on 09 mar 2021 from the nurse of a (b)(6) male with a medical history including hypertension, type ii diabetes, chronic systolic heart failure, morbid obesity, anemia, heart disease, pulmonary hypertension and end stage renal disease, who stated the patient coded during a hemodialysis treatment on (b)(6) 2021. Additional information was received on 10 mar 2021 from the nurse stating approximately one minute into treatment the patient stated he did not feel well and was short of breath. Treatment was terminated, 2l nasal oxygen was applied and intravenous saline was administered. Within minutes the patient became unresponsive, was placed in trendelenburg position, and an automated external defibrillator advised compressions with no shock advised. 911 was called and compressions commenced until emergency medical services (ems) arrived on the scene. Resuscitation efforts were unsuccessful, and the patient expired after being transported to the hospital, time not provided. Per the htn, the cause of death was undetermined.

• 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: nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 11580949
• MDR Text Key: 242676224
• Report Number: 3003464075-2021-00013
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K050525
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/29/2021 Patient Sequence Number: 1