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

Model Number FW-200

Device Problems Fire (1245); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation which confirmed the presence of burn marks were limited to the external surface of the device.No burn damage was found inside the unit and the source of the burn was identified as a short in the universal power cord.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 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.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 at the facility or during use are unknown.Udi:(b)(4).

Event Description

A report was received on (b)(6) 2020 from a biomed at a critical care facility who stated the fluid warmer caught fire on (b)(6) 2020.Additional information was received on 17 jun 2020 from the biomed who stated fluid splashed on the rear power receptacle of the device while it was in the intensive care unit, followed by a spark and fire when staff began to put the machine into use.No harm to property or person was reported.

• 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: 10271106
• MDR Text Key: 199454922
• Report Number: 3003464075-2020-00039
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): Y
• 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: 01/01/2005,07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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