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

Model Number	CAR-500
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: HIGH PERMEABILITY HEMODIALYSIS SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 11757221
• Report Number: 3003464075-2021-00019
• Device Sequence Number: 19959123
• Product Code: KDI
• UDI-Device Identifier: M535CAR5000
• UDI-Public: +M535CAR5000/$$082201278003N
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133547
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR