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

Model Number CAR-500

Device Problems Fluid/Blood Leak (1250); Therapeutic or Diagnostic Output Failure (3023); Air/Gas in Device (4062)

Patient Problem Cardiac Arrest (1762)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

The cartridge was not available for evaluation.A review of the device history record (dhr) was conducted for the reported lot number and confirmed the product was released for distribution having met quality and manufacturing specifications and requirements.The nxstage system one user guide and car-500 instructions for use (ifu) provide information and warnings for use of the device.The user guide states "do not attach ancillary devices that can restrict blood flow, such as stopcocks, to the patient lines" as well as "failure to make the proper connections may cause compromised treatment, blood loss, injury or death".A trained and qualified person must observe all treatments, check the system for blood and fluid leaks during treatment, and pay close attention to the blood lines and access connections ensuring all manual connections are secure and fluid tight.

Event Description

A report was received on (b)(6) 2021 from the health professional of a (b)(6) critical care patient with multiple comorbidities and pneumonia secondary to covid-19, stating the patient coded while connected to unspecified equipment for extracorporeal membrane oxygenation (ecmo) and performing continuous veno-venous hemofiltration (cvvh) therapy with the nxstage device on (b)(6) 2021.Additional information was received on 22 apr 2021 from the cardiovascular intensive care unit nurse manager (nm) stating that the cvvh was connected to the patient via dedicated access that lost functionality and cvvh was switched to run via the ecmo circuit.Once connected to the ecmo, a "large amount" of air was entrained and an unspecified amount of blood was noted on the floor.Air removal was successful.After the code the patient received two units of packed red blood cells, was neurologically intact and following commands.

• 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: nxstage medical, inc; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 11757221
• MDR Text Key: 248401477
• Report Number: 3003464075-2021-00019
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR5000
• UDI-Public: +M535CAR5000/$$082201278003N
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133547
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 01278003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR