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

Model Number NX1000-1

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Reaction (2414); No Code Available (3191)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

The available information does not indicate that there was a device malfunction. A device history review (dhr) of the equipment involved in this event showed that there were no defects during the manufacturing process. Though requested, additional information was not provided.

Event Description

A report was received from the facility center nurse on (b)(6) 2017 that a (b)(6) female patient with a history of cardiac disease and dementia had a reaction while receiving standard hemodialysis therapy. Additional information provided by the nurse revealed that the patient had experienced shortness of breath, irregular heart rhythm and chest heaviness within the first two minutes of commencing treatment. The patient received oxygen, was admitted to hospital and discharged on (b)(6) 2017. No information regarding treatment while hospitalized or a discharge diagnosis is available.

• 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 ; 9786874700
• MDR Report Key: 6891605
• MDR Text Key: 87321240
• Report Number: 3003464075-2017-00045
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NX1000-1
• Device Catalogue Number: CYC-D2E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 09/25/2017 Patient Sequence Number: 1