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

Model Number NX2000-1

Device Problem Fire (1245)

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

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation and displayed signs of a high energy event.External inspection of the power entry module and power cord found evidence of damage consistent with fluid ingress to the power connection.Internal inspection of the control unit showed no damage due to high heat.A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release.The device meets requirements for electrical and safety standards as outlined in the user guide.The user guide contains a precaution to verify the control unit and power cord show no sign of external damage prior to use.If the unit is damaged, follow the product return procedure described in this manual.It warns to plug the unit into a properly grounded outlet and describes connection for the power cord from a grounded power outlet to the back of the unit.Per the user guide proper electrical hookup in full compliance with all applicable codes and device specifications must be maintained.Details of the electrical connections made during use are unknown.Udi: (b)(4).

Event Description

A report was received on (b)(6) 2022 from a 51 year old male patient with a medical history including diabetes and end stage renal disease, who stated their pureflow sl control unit caught fire during a home hemodialysis treatment on (b)(6) 2022.Additional information was received on 29 aug 2022 from the home therapy nurse (htn) who confirmed there was no adverse impact to the user or operator.

• 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: 15454362
• MDR Text Key: 300267624
• Report Number: 3003464075-2022-00053
• Device Sequence Number: 1
• Product Code: FKR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111174
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NX2000-1
• Device Catalogue Number: PUREFLOW SL CONTROL UNIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 88 KG