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

Model Number FW-200

Device Problem Flare or Flash (2942)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Evaluation of photos provided showed signs of soot and burn marks consistent with involvement in a ¿high heat¿ event on the back of the fluid warmer around the power entry module.The root cause of the burn mark could not be determined from the available information.All devices must meet quality requirements and manufacturing specifications prior to release.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.

Event Description

A report was received on 29 nov 2023 from the biomedical technician of a critical care patient of unspecified pathology, who stated the fluid warmer caught on fire during a continuous renal replacement therapy (crrt) on (b)(6) 2023.Additional information was received on 14 dec 2023 from the biomedical technician who stated there was no adverse impact to the patient or operator.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: 18380914
• MDR Text Key: 331177041
• Report Number: 3003464075-2023-00114
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FW-200
• Device Catalogue Number: COMFORTMATE FLUID WARMER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2008
• 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