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

Model Number FW-300

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

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

Event Date 07/02/2022

Event Type  malfunction  

Event Description

A report was received on (b)(6) 2022 from a 49-year-old male patient with a medical history including end stage renal disease, who contacted technical support stating the power cord for the express fluid warmer was damaged by fire caused by a therapy fluid leak that occurred during a hemodialysis treatment on 02 jul 2022.There was no report of additional damage or medical intervention being required.Additional information was received on (b)(6) 2022 from the home therapy nurse (htn) confirming that there was no additional damage and that there were no symptoms experienced.Per the htn, the patient continues to treat with the nxstage system and will be reeducated on proper connections.

Manufacturer Narrative

The device was received for evaluation which confirmed the damage was localized to the external area around the power cord and inlet with no internal damage.The unit construction complies with (b)(4) standards to prevent the likelihood of sustained fire.The material for the unit is flame retardant as per the applicable rating (ul94v-0).(b)(4).

• 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
• MDR Report Key: 15065115
• MDR Text Key: 296298161
• Report Number: 3003464075-2022-00031
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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: 07/14/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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
• Patient Age: 49 YR
• Patient Sex: Male