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

Model Number FW-300

Device Problems Fire (1245); Smoking (1585); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

The warmer was received for evaluation and found no melting on the exterior surface.Some black soot-like material was noted and the power cord was melted to the ac inlet.No other component was visibly damaged.A review of the device history record (dhr) was performed and shows the unit was released for distribution having met all product design requirements.The express fluid warmer meets requirements for electrical and safety standards as outlined in the user guide.The user guide warns that the express fluid warmer must be plugged into the ac power accessory outlet on the back of the nxstage system one cycler and that the power interconnect cord must be inspected before each use.It states that proper electrical hookup in full compliance with all applicable codes and device specifications must be maintained.Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on (b)(6) 2017 regarding patient hh, a (b)(6) year old female.The report states that the express fluid warmer (efw) sparked, smoked and caught fire.The patient was not connected to the device at the time of the event.Damage was confined to the efw and there was no damage to the patient's home.There were no injuries related to the event and no medical intervention was required.

• 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 ; 9786874700
• MDR Report Key: 6807815
• MDR Text Key: 83313218
• Report Number: 3003464075-2017-00037
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K071263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FW-300
• Device Catalogue Number: FW-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 117