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

Model Number CAR-172-C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Dyspnea (1816); Fatigue (1849); Hemorrhage/Bleeding (1888)

Event Date 09/17/2023

Event Type  Injury  

Manufacturer Narrative

The cartridge was discarded and not received for evaluation.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 nxstage system one user guide includes warnings to always tighten and recheck patient vascular access and all fluid lines, connections, caps, and clamps.In addition, the instructions for use include a warning to secure caps and close clamps after priming and after each use to prevent blood loss or air entering the patient bloodlines.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 26 sep 2023 from the home therapy nurse (htn) of a 79 year old male patient with a medical history including diabetes and end stage renal disease, who stated blood was observed leaking from the heparin line during a home hemodialysis treatment on (b)(6) 2023.Additional information was received on 27 sep 2023 from the htn who stated the patient experienced shortness of breath and fatigue.They patient went to the emergency department (ed) and received a blood transfusion.Following the event the patient has recovered and will continue to treat in-center 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: 17906127
• MDR Text Key: 325308871
• Report Number: 3003464075-2023-00087
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR172C0
• UDI-Public: +M535CAR172C0/$$0424210770595
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/10/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2024
• Device Model Number: CAR-172-C
• Device Catalogue Number: CAR-172-C
• Device Lot Number: 21077059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 65 KG