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

Model Number NX1000-16-A

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

Patient Problem Convulsion/Seizure (4406)

Event Date 09/29/2022

Event Type  Injury  

Event Description

A report was received on 03 oct 2022 from the caregiver of a 51 year old female patient with a medical history of multiple comorbidities and end stage renal disease, stating the patient experienced ''seizure like'' activity during a hemodialysis treatment on (b)(6) 2022.911 was called and the patient was transported to hospital.Additional information was received on 05 oct 2022 by the home therapy nurse (htn) who stated the patient was admitted to hospital on (b)(6) 2022, a seizure medication (nos) was initiated, and was discharged on (b)(6) 2022.Although requested, no additional information regarding the course of hospitalization was provided.

Manufacturer Narrative

The involved cycler was not received for evaluation.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 evaluated log file supported the performance was without deficiency and was unremarkable.There was no indication of a device malfunction from the available information.The nxstage system one user guide outlines risks associated with performing hemodialysis therapy and warns that treatment should only be performed by a trained and qualified person who must respond promptly to harmful conditions during treatment.Udi: (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: 15669006
• MDR Text Key: 302396701
• Report Number: 3003464075-2022-00066
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170469
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NX1000-16-A
• Device Catalogue Number: CYCLER VERSIHD 1.0, NO NIBP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 120 KG