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

Model Number CAR-170-C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Cough (4457)

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

The cartridge was received for evaluation and confirmed a leak in the arterial 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".

Event Description

A report was received on (b)(6) 2022 from the home therapy nurse (htn) of a 62 year old male with a medical history including end stage renal disease, who stated the patient experienced a coughing sensation during a home hemodialysis treatment on (b)(6) 2022.After treatment was ended blood was observed leaking from the cartridge.Additional information was received on (b)(6) 2022 from the htn who stated the patient lost one circuit of blood.The patient did not experience any additional symptoms and no medical intervention was required.Following the event the patient has recovered without sequelae and resumed treatment with the nxstage system.Follow up information was received on (b)(6) 2022 from quality engineering confirming the integrity of the cartridge was compromised.

• 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
• MDR Report Key: 14655626
• MDR Text Key: 301274135
• Report Number: 3003464075-2022-00026
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2023
• Device Model Number: CAR-170-C
• Device Catalogue Number: CAR-170-C
• Device Lot Number: 11077016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• 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): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 127 KG