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

TPLC - Total Product Life Cycle

  • 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
 

New Search Back To Search Results
Device hemodialysis system for home use
Regulation Description High permeability hemodialysis system.
Definition To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Product CodeONW
Regulation Number 876.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 24
Device operates differently than expected 21
Mechanical issue 19
Fluid leak 16
Reflux within device 15
Mechanical jam 4
Disconnection 3
Use of Device Issue 3
Blockage within device or device component 3
Failure to deliver 2
No Information 2
Power source issue 1
Pressure issue 1
Pumping issue 1
Ultrafiltration 1
Electronic property issue 1
Computer software issue 1
Device alarm system issue 1
Failure to Adhere or Bond 1
Fracture 1
Misconnection 1
Total Device Problems 122

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Holdings, Inc. II Nov-08-2013
2 Fresenius Medical Care Holdings, Inc. II Aug-29-2011

-
-