MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	CAR-505
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Rn started setting up crrt.However, the machine was continuously alarming alert 85- check cartridge waste line failure.After following the procedure to fix this issue, the machine continued to alarm.After 3 attempts, the machine continued to alarm.The rn then switched out the cartridge 3 times.The same alarm sequence occurred.It was then determined that we were dealing with a defective batch of crrt cartridges, and all were from the same lot number.This caused a delay in the patient receiving life-saving crrt.Manufacturer response for dialyzer, high permeability with or without sealed dialysate system, nxstage cartridge express (per site reporter).Unknown.

• Brand Name: NXSTAGE CARTRIDGE EXPRESS
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 25592465
• Report Number: 25592465
• Device Sequence Number: 20204023
• Product Code: KDI
• UDI-Device Identifier: M535CAR5050
• UDI-Public: M535CAR5050
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/19/2026
• Report Date (Section F): 06/19/2026

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
• Operator of Device: Health Professional
• Device Model Number: CAR-505
• Device Lot Number: 50878020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 06/19/2026