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 Dizziness (2194); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

The cycler was not provided for evaluation.A review of the device history record (dhr) of the reported serial number confirmed the device was released for distribution having met all product design requirements.Udi for nx1000-1: (b)(4).Nxstage medical considers this report closed.No additional information will be provided.

Event Description

A report was received on (b)(6) 2019 from a (b)(6) male with multiple comorbidities including congestive heart failure, aortic stenosis, permanent pacemaker and hypertension who stated he felt dizzy, passed out and experienced tremors on regaining consciousness during a standard hemodialysis treatment on (b)(6) 2019.The patient stated that he had experienced the symptoms when increasing the blood flow rate, had rinsed back the circuit of blood and called emergency services who transported him to hospital.Additional information was received on (b)(6) 2019 from the home therapy nurse (htn) stating the patient was hospitalized from (b)(6) 2019.The hospital discharge summary received on 1 mar 2019 revealed the patient had been evaluated via chest x-ray and chest ct for a pulmonary embolus, with inconclusive findings.Testing for peripheral deep vein thrombosis was negative.Dialysis therapy was provided in the hospital without event and the patient was discharged (b)(6) 2019 with no further treatment or symptoms reported.

• 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: 8409784
• MDR Text Key: 138458684
• Report Number: 3003464075-2019-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K050525
• 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: 01/01/2005,03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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: NX1000-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 75