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 Chest Pain (1776); Dyspnea (1816); Pain (1994); Blurred Vision (2137)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

The involved cycler was not received for evaluation.All devices meet quality criteria and manufacturing specifications prior to release.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.

Event Description

A report was received on 17 nov 2022 from a healthcare professional (hcp) regarding female patient sl, who stated the patient experienced chest tightness, difficulty breathing, lower back pain, and blurry vision during a home hemodialysis treatment on an unspecified date.The patient was admitted to hospital on (b)(6) 2022.Additional information was received on 23 nov 2022 from the hcp stating the symptoms onset approximately two minutes into the treatment on (b)(6) 2022 and treatment was ended.The patient has since recovered without sequelae and performed hemodialysis treatment with a machine and dialyzer from a different manufacturer without issue.

• 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: 15914162
• MDR Text Key: 304783372
• Report Number: 3003464075-2022-00080
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E W/ SERVICE COMPUTER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2012
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 55 KG