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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
Lot Number 91078006 AND 90678009
Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2020
Event Type  malfunction  
Event Description
We have continued to have problems with our nxstage continuous renal replacement therapy bags. This is a continuous dialysis type of procedure that we use on our very critically ill patients and these failures are expensive and cause delays in patient care. 2 minutes into priming the machine alarmed arterial air. The fluid appeared sluggishly to be priming through the filter. We tried starting over with the same filter but were unable to do the recovery. The fluid wouldn't drain back into the priming bag. A new filter was set up and worked fine. Car 500 filter, lot 91078006. Manufacturer response for continuous renal replacement solutions, nxstage (per site reporter). This has been an ongoing issue lately, we've had several bag lot numbers that have not worked, or have malfunctioned in some way. We have serious quality concerns with nxstage and do not have a resolution as of yet.
 
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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 street
lawrence MA 01843
MDR Report Key9933750
MDR Text Key186763758
Report Number9933750
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 02/07/2020,02/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2020
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number91078006 AND 90678009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2020
Event Location Hospital
Date Report to Manufacturer04/08/2020
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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