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

Device Problems Fluid/Blood Leak (1250); Failure to Prime (1492); Material Rupture (1546); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Event Description

Continue to have ongoing issues with multiple crrt bags and filters.Car 500 crrt filter alarming high venous pressures while priming.Unable to complete prime.Crrt machine (33653) ran well when different cartridge was put in.Lot #90678009.Car 500 nxstage filter & cartridge was faulty.The red port that connects to the saline bag is not patent.Tubing pinched together therefore unable to prime or open to return blood.Lot 90678009.Nxstage crrt bag rfp-401.Bag leaking when opened.Lot number q1910715.Crrt bag burst when opened.Lot: q1909648.

• Brand Name: NXSTAGE
• 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: 9659314
• MDR Text Key: 177376149
• Report Number: 9659314
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1