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

Model Number NX1000-16-A

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

Patient Problems Cardiac Arrest (1762); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/02/2021

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.Per log file review automated rinseback was not performed.A review of the device history record confirmed the product was released meeting all product design specifications and quality criteria.The system one user guide includes instructions for automated rinseback and warns to not attempt manual rinseback if the blood circuit is clotted or hemolyzed, or if you see air within the blood circuit or in the patient blood lines, or if otherwise directed by the center.(b)(4).

Event Description

A report was received on 04 aug 2021 from the home therapy nurse (htn) of an (b)(6) male with an extensive medical history including hypotension and end stage renal disease, who stated the patient expired after completing rinseback following a home hemodialysis treatment on (b)(6) 2021.Additional information was received on 05 aug 2021 from the htn who stated, the patient elected to terminate treatment after unsuccessfully troubleshooting air alarms approximately nineteen minutes into therapy.Per the htn, the patient was lightheaded after rinseback, and became unresponsive.Emergency medical services (ems) were called, determined that the patient was in cardiac arrest and transported the patient to hospital.The patient subsequently expired later that day, time unspecified.The htn stated that the patient was "off the machine" when the event occurred, and the death was unrelated to nxstage product and therapy.

• 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: 12420968
• MDR Text Key: 269747804
• Report Number: 3003464075-2021-00040
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170469
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-16-A
• Device Catalogue Number: CYCLER VERSIHD 1.0, NO NIBP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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: 81 YR