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

Model Number FW-300

Device Problems Fire (1245); Electrical Shorting (2926)

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

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation which confirmed the damage was localized to the external area around the power inlet with no internal damage.The unit construction complies with iec-60601-1 standards to prevent the likelihood of sustained fire.The material for the unit is flame retardant as per the applicable rating (ul94v-0).The express fluid warmer user guide provides instruction for use of the device and states "use only the power cords supplied by nxstage or its authorized distributors.Do not connect portable multiple-socket outlets or extension cords to any nxstage equipment.Non-authorized or incompatible electrical power cords and outlets can create an electrical hazard." (b)(4).

Event Description

A report was received on (b)(6) 2020 from the care partner of a (b)(6) male with a medical history of end stage renal disease, stating the express fluid warmer caught fire after fluid dripped into the device while preparing for a home hemodialysis treatment on (b)(6) 2020.Additional information was received on 02 dec 2020 from the home therapy nurse (htn) who stated the patient was not connected to the device at the time of the event and there was no patient harm or damage to property.Per the htn there was a short in the home circuit breaker affecting the usual power outlet used by the patient.The device was connected via an extension cord to a power outlet in another room and the patient was preparing the device for initiation of treatment.The htn stated the patient continues to treat using the nxstage system and a replacement device.

• 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: 11041645
• MDR Text Key: 222853886
• Report Number: 3003464075-2020-00083
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K071263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FW-300
• Device Catalogue Number: EXPRESS FLUID WARMER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR