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

Model Number NX1000-5

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Myalgia (2238)

Event Date 11/03/2019

Event Type  Death  

Manufacturer Narrative

The involved cycler was not received for evaluation.Review of the log file for the event found that the device was functioning as designed and intended with no indication of a device malfunction.All product is released meeting all quality criteria and manufacturing specifications and the available information supports that there was no device malfunction.

Event Description

A report was received on (b)(6) 2019 from a nurse regarding a patient in critical care for unspecified pathology, stating the patient expired during a continuous renal replacement therapy (crrt) treatment on (b)(6) 2019.Prior to treatment the nurse stated the patient had received benadryl, pepcid, and solumedrol (doses, route and reason for administration not provided).After approximately 45 minutes of therapy the patient experienced restless legs and low blood pressure (~60/30) before all pressures were lost.45-60 minutes of resuscitative measures were performed unsuccessfully and the patient expired.Although requested, no additional information has been 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: 9384880
• MDR Text Key: 168272761
• Report Number: 3003464075-2019-00069
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133547
• 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: 01/01/2005,11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NX1000-5
• Device Catalogue Number: ACUTE CYCLER 3RD ED W/ ONEVIEW
• 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: 11/03/2019
• Date Device Manufactured: 09/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death