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

Model Number CAR-505

Device Problems Fracture (1260); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

The cartridge was discarded and not available 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 instructions for use states "make sure mated luer-connectors are secure but do not over-tighten, especially when connections are wet.".

Event Description

A report was received on (b)(6) 2023 from the clinical nurse manager (nm) at a critical care facility regarding a patient with unspecified pathology, who stated the cartridge luer connector broke when attempting rinseback of a continuous renal replacement therapy (crrt) and blood could not be returned to the patient on (b)(6) 2023.Additional information was received on (b)(6) 2023 from the nm stating that there were no symptoms or medical intervention required and that patient continued therapy with the nxstage system using a new cartridge.

• 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: 16688731
• MDR Text Key: 312765296
• Report Number: 3003464075-2023-00030
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: M535CAR5050
• UDI-Public: +M535CAR5050/$$022420978003W
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133547
• 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: 04/06/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Device Lot Number: 20978003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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): Other