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

Model Number FW-300

Device Problem Fire (1245)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation and found to have signs of soot and burn marks consistent with involvement in a ¿high heat¿ event.The inside of the fluid warmer was inspected and showed no evidence of corrosion or fluid ingress.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 verify the fluid warmer and power cord show no sign of external damage prior to use.If the unit is damaged, follow the product return procedure described in this manual.It warns to plug the warmer into a properly grounded outlet and describes connection for the power cord from a grounded power outlet to the back of the warmer.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 21 jun 2023 from a 53 year old male patient with a medical history including end stage renal disease, who stated flames were observed coming from the express fluid warmer during a home hemodialysis treatment on (b)(6) 2023.Additional information was received on 29 jun 2023 from the home therapy nurse (htn) who stated the event occurred during treatment with no adverse impact to the user.Following the event the patient continues to treat using 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: 17328114
• MDR Text Key: 319065021
• Report Number: 3003464075-2023-00054
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2023

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: FW-300
• Device Catalogue Number: EXPRESS FLUID WARMER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 108 KG