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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, dialysate delivery, sealed
Regulation Description High permeability hemodialysis system.
Product CodeFII
Regulation Number 876.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
GAMBRO
  SUBSTANTIALLY EQUIVALENT 2
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Normal 67
Disconnection 21
Fluid leak 14
Calibration error 12
Defective component 10
Fluid/volume, increased 8
Conductivity 6
Device alarm system issue 5
Malfunction 4
Component(s), worn 4
Pre or post-pumping problem 4
Failure, intermittent 4
Alarm, failure of low flow 4
Improper or incorrect procedure or method 3
Inaccurate flowrate 3
Dislodged 3
Leak 3
Sensor problems 2
Electrical wires, defective 2
Bubble detector, failure of 2
Method, improper/incorrect 2
Loose or intermittent connection 2
Other (for use when an appropriate device code cannot be identified) 2
Parameter calculation error due to software problem 2
Device inoperable 2
Incorrect measurement 2
Failure to pump 2
Unknown (for use when the device problem is not known) 2
Dose calculation error due to software problem 2
Percutaneous 1
Increase in pressure 1
Residue after decontamination 1
Device displays error message 1
Locking mechanism failure 1
Not audible alarm 1
Occlusion, incorrect 1
Alarm, audible 1
Computer failure 1
False reading from device non-compliance 1
Inaccurate delivery 1
Improper flow or infusion 1
Device Rinsing Issue 1
Computer software issue 1
Accuracy rate 1
Alarm, failure of warning 1
Device Issue 1
Pressure issue 1
Total Device Problems 217

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 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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