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

Model Number NX1000-3-A

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

Patient Problems Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Itching Sensation (1943); Loss of consciousness (2418)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

The involved cycler was not received for evaluation.A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.There is no information to indicate that a malfunction occurred.Udi #: (b)(4).This report and the information contained herein is submitted to the applicable competent authority under medical device directive 93/42/eec and represents the information available to the company at the time of the report.

Event Description

A report was received on (b)(6) 2019 from the nurse of a (b)(6) female with a medical history significant for hypertension, diabetes and itching prior to her hemodialysis treatment that day, who experienced worsened itching within approximately 4 minutes of initiating her first hemodialysis treatment on (b)(6) 2019.Treatment was terminated with rinseback after which the patient developed shortness of breath and became unresponsive.A pulse was present and emergency services were contacted who transported the patient to the hospital critical care unit with an admitting diagnosis of cardiac arrest.Additional information was received on (b)(6) 2019 from the nurse stating resuscitation efforts had been initiated prior to arrival of emergency services with cardiac arrest occurring en route to the hospital.Available information indicates the patient did not respond to resuscitative efforts with details of outcome requested but not provided.

• 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: 8684218
• MDR Text Key: 147571177
• Report Number: 3003464075-2019-00027
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NX1000-3-A
• Device Catalogue Number: CHRONIC HI-FLOW CYCLER, ROHS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Weight: 65