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

Model Number CAR-500

Device Problems Leak/Splash (1354); Defective Device (2588); Material Deformation (2976); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

(b)(4) primary rn initiated avvh (accelerated venovenous hemofiltration) treatment for patient.Shortly after initiation, rn noticed replacement fluid dripping from the nxstage machine.Per rn, fluid was dripping very fast.Blood returned to patient and rn removed cartridge and inspected it.Replacement fluid appeared to be leaking from balance chamber area.Educator notified, nxstage representative has been contacted about the issue.Defective cartridge was not saved.Car 500 crrt cartridge for nxstage system one.(b)(4) - rn went to start cvvh (continuous venovenous hemofiltration) and the tubing on the cartridge was crimped and were unable to use this cartridge (b)(4), lot# 10778017.(b)(4) - patient on continuous dialysis (cvvh) - cvvh machine with frequent therapy fluid inlet air detected alarms that started overnight.Upon closer inspection this morning tubing on fluid warmer kinked on several of the connectors to the therapy fluid bags.Bladder on fluid warmer frequently empty and difficult to fill.Opened 2 new sets of tubing that was left over from other cartridges (same lot number) and several of the connectors noted to be very kinked as well.One set of connectors without any kinks found out of 6 (in the 2 new bags) and connected to therapy fluid bags and warmer (no alarms since).Pictures of tubing taken and also sent to umass nxstage representative.She's filling out their internal incident report and is sending box to return tubing to them (awaiting incident report number) (b)(4), lot# 10878016.(b)(4) - nurse reported that the pressures rapidly increased and then the clamp on the filter unclamped on its own, the syringe shot off, and subsequently bled onto the floor.(b)(4).

• Brand Name: NXSTAGE CARTRIDGE EXPRESS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 13076464
• MDR Text Key: 282722343
• Report Number: 13076464
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/01/2021

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 Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 10778017, 10878016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Sex: Male
• Patient Weight: 121 KG