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

Model Number NX1000-1

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2023

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation and found to have signs of a flame event that occurred in the area of the power cord connector.The findings were consistent with fluid ingress into the power cable inlet and power entry module, causing a high resistance short between the ground and line terminals on the power plug.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 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.The device meets requirements for electrical and safety standards as outlined in the user guide.The user guide contains a precaution to inspect all nxstage system one cycler components for damage before use.If product is damaged, follow the procedures to return the product included in this user guide.It warns to plug the device into a properly grounded outlet and describes connection for the power cord from a grounded power outlet to the back of the device.Per the user guide proper electrical hookup in full compliance with all applicable codes and device specifications must be maintained.Details of the electrical connections or during use are unknown.Udi: (b)(4).

Event Description

A report was received on (b)(6) 2023 from the caregiver (cg) of a 66-year-old male patient with a medical history including hypertension and end stage renal disease, who stated there was a ¿loud pop and flash¿ from the cycler on (b)(6) 2023.There is no report of medical intervention being required.Additional information was received on 19 oct 2023 from the home therapy nurse (htn) who stated there was no impact to patient or caregiver and the patient continues to treat with the nxstage system.

• 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: 18096883
• MDR Text Key: 327678990
• Report Number: 3003464075-2023-00098
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Device Lot Number: 11566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2010
• 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): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 105 KG