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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number SEE ATTACHMENT
Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2019
Event Type  malfunction  
Event Description
Devices purchased in 2015 are experiencing more frequent system failures requiring high cost repairs.Models prior to and after 2015 are not experiencing the same degree of failures.Our concern is that changes to the manufacturing process or changes to suppliers for components may have contributed to these failures.Manufacturer response for continuous renal replacement therapy, nxstage system one (per site reporter).No specific response given to vintage year 2015 concerns, but given the opportunity to upgrade if desired.
 
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Brand Name
NXSTAGE SYSTEM ONE
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 Key9244368
MDR Text Key163938064
Report Number9244368
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 Biomedical Engineer
Type of Report Initial
Report Date 09/09/2019,09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSEE ATTACHMENT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/09/2019
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer10/28/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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