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 Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

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 and showed the power entry module and grounding cable were corroded which caused electrical shortage.The device meets requirements for electrical and safety standards as outlined in the user guide.The user guide states to inspect the power interconnect cord and the device for damage before each use, and not to use the device if any damage is evident.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.

Event Description

A report was received on (b)(6) 2020 from the biomed of a critical care facility, stating the device caught fire during a hemodialysis treatment on (b)(6) 2020.Additional information was received 22-24 jul 2020 from the biomed stating the damage was confined to the fluid warmer which was removed from use.There was no patient injury 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: 10419480
• MDR Text Key: 203882688
• Report Number: 3003464075-2020-00047
• 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: 01/01/2005,08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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: 08/10/2020
• 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: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other