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

Model Number CAR-535

Device Problems Mechanical Problem (1384); Fitting Problem (2183)

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

Event Date 03/06/2023

Event Type  malfunction  

Event Description

Rn went to change filter on speedswap cartridge 535 lot# 20278014 and was unable to do so because the filter had wrong female to male connector in place.Rn had to stop treatment and re-prime new car-535 cartridge.Nxstage representative notified and speedswap filter to be sent for evaluation.

• Brand Name: NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 16589969
• MDR Text Key: 311763601
• Report Number: 16589969
• 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
• Report Date: 03/09/2023

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 Model Number: CAR-535
• Device Catalogue Number: CAR-535
• Device Lot Number: 20278014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1