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

Model Number NX1000-16

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

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418)

Event Date 11/19/2023

Event Type  Death  

Event Description

A report was received on 21 nov 2023 from the home therapy nurse (htn) of a 47 year old male patient with an extensive medical history including end stage renal disease, who stated the patient went into cardiac arrest during a home hemodialysis treatment on (b)(6) 2023.Additional information was received on 27 nov 2023 from the htn, who stated the patient was about an hour into treatment when he lost consciousness and the caregiver called emergency medical services.Per the htn the patient subsequently expired at an unspecified time on (b)(6) 2023.

Manufacturer Narrative

The device was received for evaluation and successfully passed testing.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.Available log files were retrieved and analyzed which showed device performance was without deficiency and was unremarkable.There was no indication of a device malfunction from the available information.The nxstage system one user guide outlines risks associated with performing hemodialysis therapy and warns all treatments must be administered under a physician''s prescription and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.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 ; 9784505276
• MDR Report Key: 18357379
• MDR Text Key: 330896350
• Report Number: 3003464075-2023-00112
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 12/19/2023

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: NX1000-16
• Device Catalogue Number: CYCLER VERSIHD 1.0, NO NIBP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2021
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 115 KG