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

Model Number	CAR-500
Health Effect - Clinical Code	Anemia (1706)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received on 10 aug 2022 from the critical care nurse (ccn) of a critically ill patient with unspecified pathology, who stated an unspecified amount of blood leaked approximately 24 hours into a continuous renal replacement therapy (crrt) on (b)(6) 2022.Per the ccn, the patient experienced a 1g/dl decrease in hemoglobin, received one unit of blood, recovered to baseline status and resumed crrt.
Additional Manufacturer Narrative
The cartridge was received for evaluation and revealed a crack in the arterial luer.A device history record (dhr) review was conducted for the reported lot number and revealed the product was released for distribution having met quality and manufacturing specifications and requirements.The instructions for use states "check the system for blood and fluid leaks during treatment, and pay close attention to the blood line and access connections" and "make sure mated luer-connectors are secure but do not over-tighten, especially when connections are wet".

• Brand Name: NXSTAGE SYSTEM ONE
• Common Device Name: 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
• MDR Report Key: 15283368
• Report Number: 3003464075-2022-00041
• Device Sequence Number: 7111076
• Product Code: KDI
• UDI-Device Identifier: M535CAR5000
• UDI-Public: +M535CAR5000/$$112320578001K
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 20578001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown