MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CARTRIDGE EXPRESS DIALYZER, HIGH PERMEABILITY W OR W/O SEALED DIALYSATE SYSTEM

Model Number CAR-505

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

Staff report that the nxstage medical, inc. Cartridges, used for continuous renal replacement therapy, are only lasting 4 hours because the cartridges are separating during use.

• Brand Name: NXSTAGE CARTRIDGE EXPRESS
• Type of Device: DIALYZER, HIGH PERMEABILITY W OR W/O SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 12445944
• MDR Text Key: 270509674
• Report Number: 12445944
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2021,08/17/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CAR-505
• Device Catalogue Number: CAR-505
• Device Lot Number: 10378006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2021
• Event Location: No Information
• Date Report to Manufacturer: 09/09/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown