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

Model Number NX1000-3

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems Fall (1848); Hemorrhage/Bleeding (1888)

Event Date 12/08/2021

Event Type  Death  

Event Description

A report was received on 09 dec 2021 from the home therapy nurse (htn) of a (b)(6)female with a medical history including end stage renal disease approved for performing solo home hemodialysis treatment, who stated the patient passed away approximately an hour into a home hemodialysis treatment on (b)(6) 2021.Additional information was received on 17 dec 2021 from the htn who stated the patient was found face down on the floor at an unspecified time during treatment with the arterial blood line disconnected and surrounded by blood (amount not provided).Emergency medical services were called, cardiopulmonary resuscitation was performed, a defibrillator was applied, and medication (nos) was given.Per the htn the cause of death has not been determined.

Manufacturer Narrative

The device was received for evaluation and successfully passed testing with no malfunction found.Available log files were retrieved and analyzed which showed the cycler performed as intended and alarmed appropriately when the alarm conditions were present.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 supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient.Udi: (b)(4).

• 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: 13170494
• MDR Text Key: 283265808
• Report Number: 3003464075-2022-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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: 12/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2018
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 62 KG