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

Model Number	CAR-505
Medical Device Problem Codes	Fluid/Blood Leak (1250); Use of Device Problem (1670)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cartridge was received for evaluation and there was no malfunction.During testing, no leaks were found and all clamps and caps functioned as designed.The source of the blood leak could not be determined.A device history record (dhr) review was conducted for the reported lot number and confirmed the product was released for distribution having met quality and manufacturing specifications and requirements.The instructions for use warns "secure caps and close clamps after priming and after each use to prevent blood loss or air entering the patient blood lines.¿ all treatments must be administered under a physician's prescription and performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician so that alarms and harmful conditions can be responded to promptly.
Event or Problem Description
A report was received on 06 aug 2024 from a nurse regarding a 68 year old male critical care patient with comorbidities including cholangiocarcinoma and hypertension, who stated the patient became symptomatic when approximately 500ml blood leaked from the cartridge bloodline during continuous renal replacement therapy (crrt) on (b)(6) 2024.The patient¿s vasopressor therapy was titrated (norepinephrine bitartrate/levophed and phenylephrine) and 1l of lactated ringers was administered to address the acute event, followed by one unit of packed red blood cells fluids.Additional information was received on 12 aug 2024 from the nurse who stated the patient experienced hypotension, tachycardia, and anemia.Per the nurse, the patient continued to receive therapy with the nxstage system.

• 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: 20089181
• Report Number: 3003464075-2024-00251
• Device Sequence Number: 7561801
• Product Code: KDI
• UDI-Device Identifier: M535CAR5050
• UDI-Public: +M535CAR5050/$$122540678011W
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/28/2024

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: 12/01/2025
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Device Lot Number: 40678011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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 Age: 68 YR
• Patient Sex: Male