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U.S. Department of Health and Human Services

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

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NXSTAGE MEDICAL, INC. NXSTAGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Fluid 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.
 
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Brand NameNXSTAGE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack st
lawrence MA 01843
MDR Report Key9659314
MDR Text Key177376149
Report Number9659314
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/03/2020
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/18/2019
Event Location Hospital
Date Report to Manufacturer02/03/2020
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? No
Type of Device Usage

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