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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 22
Mechanical issue 20
Fluid leak 16
Reflux within device 16
Mechanical jam 4
Disconnection 3
Use of Device Issue 3
Blockage within device or device component 3
Device alarm system issue 2
Failure to deliver 2
No Information 2
Power source issue 1
Pressure issue 1
Pumping issue 1
High pH 1
Ultrafiltration 1
Electronic property issue 1
Failure to Adhere or Bond 1
Computer software issue 1
Fracture 1
Misconnection 1
Total Device Problems 127

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 1 0 0 0 0
Class III 0 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

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