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 Material Puncture/Hole (1504); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2020

Event Type  malfunction  

Event Description

Perfusionist replacing crrt machine filter when he noticed the new filter tubing had a hole and defect in the tubing.Inspection of the tubing occurred prior to set-up and was never attached to the patient/used.

• 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: 10430422
• MDR Text Key: 203665578
• Report Number: 10430422
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CAR-500
• Device Catalogue Number: CAR-500
• Device Lot Number: 91278006
• 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: 08/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1