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

Model Number CAR-172-C

Device Problems Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

The cartridge was received for evaluation and visual inspection found evidence of a blood leak.The origin of the 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 states "check the system for blood and fluid leaks during treatment, and pay close attention to the blood line and access connections." 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 Description

A report was received on 08 feb 2024 from a health care professional of a 60 year old female patient with a medical history including end stage renal disease, who stated a cartridge blood leak was observed during a hemodialysis treatment on (b)(6) 2024.Additional information was received on 08 feb 2024 from the home therapy nurse (htn) who stated the patient did not experience any symptoms or require medical intervention.Per the htn, the patient continues to treat with the nxstage system.

• 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: paula rogalski ; nxstage medical, inc.; 350 merrimack street; lawrence, MA 01843 ; 9784505276
• MDR Report Key: 18821995
• MDR Text Key: 337639087
• Report Number: 3003464075-2024-00027
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 30977038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female