Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 CAR-500
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/04/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was not received for evaluation.All product is released meeting all product design specifications, as well as quality and manufacturing criteria prior to its release.
 
Event or Problem Description
A report was received on (b)(6) 2019 from the nurse of a critical care patient with unspecified pathology, stating that the luer connection broke on (b)(6) 2019.The patient's central venous catheter was replaced with no associated patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NXSTAGE SYSTEM ONE
Common Device Name
HIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
MDR Report Key9505034
Report Number3003464075-2019-00083
Device Sequence Number11663368
Product Code KDI
UDI-Device IdentifierM535CAR5000
UDI-Public+M535CAR5000/$$122090478014S
Combination Product (Y/N)Y
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K133547
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 12/20/2019
Report Date (Section F) 01/01/2005
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date12/01/2020
Device Model NumberCAR-500
Device Catalogue NumberCAR-500
Device Lot Number90478014
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/04/2019
Initial Report FDA Received Date12/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Date Report Sent to FDA01/01/2005
-
-