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 Apnea (1720); Cardiac Arrest (1762); Loss of consciousness (2418)

Event Date 07/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A report was received on 15 july 2021 from the nurse of a male patient with comorbidities including diabetes, pneumonia, failed transplant, recent hospitalization for sepsis and end stage renal disease, stating the patient went into cardiac arrest during a home hemodialysis treatment on (b)(6) 2021.Additional information was received on 20 jul 2021 from the home therapy nurse (htn) which revealed the patient became unresponsive and apneic at an unspecified time during a standard home hemodialysis session.The family called emergency services (ems) and commenced cardiopulmonary resuscitation (cpr) which was continued by ems who transported the patient to hospital.The patient did not regain consciousness and was admitted to the intensive care unit (icu).

• 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: 12306333
• MDR Text Key: 265974239
• Report Number: 3003464075-2021-00036
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2013
• 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; Required Intervention
• Patient Age: 49 YR