• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number NX1000-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Test Result (2695); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
A device serial number was not provided and the device was not provided for evaluation. Per the facility biomed, no further information will be provided.
 
Event Description
A report was received on 10 jan 2020 from a video journalist regarding an adult male who was denied a kidney transplant in (b)(6) 2019 (exact date not provided). Additional information was received on 10 jan 2020 from the biomed which revealed the living donor transplant was postponed because the patient had missed treatments and was uremic. Although requested, no further information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNXSTAGE SYSTEM ONE
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
Manufacturer (Section G)
MEDIMEXICO S. DE R. L. DE C. V
av. valle imperial no. 10523
parque industrial valle sur
tijuana 22180
MX 22180
Manufacturer Contact
paula rogalski
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key9612645
MDR Text Key188242058
Report Number3003464075-2020-00004
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberNXSTAGE SYSTEM ONE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/21/2020 Patient Sequence Number: 1
-
-