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

Model Number FW-200

Device Problem Fire (1245)

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

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

All devices must meet quality requirements and manufacturing specifications prior to release, and the device has not been serviced for any similar events. The device was received for evaluation which confirmed the damage was localized to the external area around the power inlet with no internal damage. Use of a third party power cord by the facility to connect the device was confirmed. The unit construction complies with iec-60601-1 standards to prevent the likelihood of sustained fire. The comfortmate fluid warmer user guide provides instruction for use of the device and states " do not connect portable multiple-socket outlets or extension cords to the nxstage system one cycler, comfortmate fluid warmer, or pureflow" sl. Use only the power cords supplied by nxstage. ".

Event Description

A report was received on 08 dec 2020 from a critical care nurse stating flame was noted after fluid leaked onto the electrical connection of the device during a hemodialysis treatment on (b)(6) 2020. Per the nurse, the flame only flashed and the device was removed from use with no patient harm or damage to property.

• 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: 11065890
• MDR Text Key: 224251930
• Report Number: 3003464075-2020-00084
• Device Sequence Number: 1
• Product Code: KDI
• 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

• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: FW-200
• Device Catalogue Number: COMFORTMATE FLUID WARMER ASSEM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/23/2020 Patient Sequence Number: 1