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

Model Number NX1000-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Chills (2191); Convulsion/Seizure (4406)

Event Date 02/03/2021

Event Type  Death  

Manufacturer Narrative

The involved device was not received for evaluation.A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.Based on the available information, there is no evidence to indicate that a malfunction occurred.A search of the complaint database revealed no other serious events associated with this device.(b)(4).

Event Description

A report was received on 03 feb 2021 from the home therapy nurse (htn) of a (b)(6) female with a medical history including end stage renal disease and coagulation defect, stating the patient expired during a hemodialysis session on (b)(6) 2021.Additional information was received on 05 feb 2021 from the htn, who stated that the patient experienced chills, decreased blood pressure and seizure prior to absence of vital signs.Per the htn, no medical intervention was provided, and the cause of death is unknown.

Event Description

Additional information was received from the htn on (b)(6) 2021 indicating the patient became symptomatic while disconnecting from the device.Per the htn, emergency services resuscitation efforts were unsuccessful, and the patient expired.No cause of death was provided.

Manufacturer Narrative

The device was received for evaluation and successfully passed the prime and alarms test confirming proper functionality of the device and sensors.Available log files were retrieved and analyzed which showed device performance was without incident and was unremarkable.All information supports the device was functioning as designed and intended with no malfunction.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 11344825
• MDR Text Key: 232433462
• Report Number: 3003464075-2021-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K050525
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 48 YR
• Patient Weight: 116