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

Model Number	CAR-500
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received on (b)(6) 2023 from the risk manager of a 61 year old female critical care patient, who stated fluid was observed leaking from the cartridge 15 minutes into a continuous veno-venous hemofiltration (cvvh) treatment on (b)(6) 2023.Additional information was received upon completion of product evaluation on (b)(6) 2023 which confirmed blood was leaking from the cartridge.Although requested, additional information regarding patient impact was not provided, there is no indication the patient experienced any symptoms related to the event and no report of medical intervention being required.
Additional Manufacturer Narrative
The cartridge was received for evaluation and revealed a leak in the venous line.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".User facility report #: 5201770000-2023-8048.

• 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 ; 9784505276
• MDR Report Key: 16626792
• Report Number: 3003464075-2023-00026
• Device Sequence Number: 12079513
• Product Code: KDI
• UDI-Device Identifier: M535CAR5000
• UDI-Public: +M535CAR5000/$$112320678013O
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 20678013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Female