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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, peritoneal, automatic delivery
Regulation Description Peritoneal dialysis system and accessories.
Product CodeFKX
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 6
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEKA RESEARCH & DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 2
Lifemed of California
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 6319
Device operates differently than expected 3603
Improper or incorrect procedure or method 3236
Fluid leak 3064
No Known Device Problem 2364
Overfill 581
Disconnection 458
Device handling issue 332
Hole in material 232
Loose or intermittent connection 203
Volume accuracy issue 188
No Information 144
Leak 141
Foreign material present in device 130
Air leak 92
Cut in material 81
Break 58
No code available 56
Use of Device Issue 55
Crack 55
Connection issue 54
Component falling 50
Device emits odor 48
Component missing 48
Overheating of device or device component 42
Device alarm system issue 33
Scratched material 28
Detachment of device component 23
Degraded 23
Grounding malfunction 21
Fitting problem 19
Smoking 17
Electrical issue 16
Material integrity issue 16
Material puncture 14
Misassembled 13
Device Issue 12
Melted 10
Occlusion within device 10
Ultrafiltration 9
Kinked 9
Material rupture 8
Invalid sensing 8
Detachment of device or device component 7
Noise, Audible 7
Inappropriate shock 7
Mechanical issue 7
Excess flow or overinfusion 7
Filling problem 7
Contamination during use 7
Tear, rip or hole in device packaging 6
Material deformation 5
Insufficient heating 5
Misconnection 5
Material separation 5
Reflux within device 5
Incorrect or inadequate result 4
Device Difficult to Setup or Prepare 4
Failure to prime 4
Collapse 4
Component(s), broken 4
Bent 4
Blockage within device or device component 4
Human-Device Interface Issue 4
Dislodged or dislocated 4
Infusion or flow issue 4
Torn material 4
Spark 4
Delivery System Issue, No Description 3
Blocked connection 3
Unknown (for use when the device problem is not known) 3
Temperature issue 3
Alarm, audible 3
Not audible alarm 3
Failure to cycle 3
Difficult to insert 3
Fire 3
Sticking 3
Device inoperable 2
Shipping damage or problem 2
Difficult to remove 2
Nonstandard device or device component 2
Incorrect measurement 2
No display or display failure 2
Incorrect display 2
Alarm not visible 2
Manufacturing or shipping issue associated with device 2
Improper flow or infusion 2
Expulsion 2
No flow 2
Other (for use when an appropriate device code cannot be identified) 2
Out-of-box failure 2
Inaccurate delivery 2
Defective component 2
Split 2
Failure to disconnect 2
Defective item 2
Disinfection or Sterilization Issue at User Location 1
Device sensing issue 1
Ambient noise issue 1
Total Device Problems 22122

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 0 0 0 0 0 0
Class II 0 1 0 1 2 2 3 0 5 3 1
Class III 0 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Aug-22-2016
2 Baxter Healthcare Corp. II Apr-25-2016
3 Baxter Healthcare Corp. III Nov-17-2015
4 Baxter Healthcare Corp. II Mar-18-2015
5 Baxter Healthcare Corp. II Feb-02-2015
6 Baxter Healthcare Corp. II Jan-29-2015
7 Baxter Healthcare Corp. II Jan-07-2015
8 Baxter Healthcare Corp. II Jan-07-2015
9 Baxter Healthcare Corporation II Jan-19-2017
10 Baxter Healthcare Renal Div II Aug-02-2012
11 Baxter Healthcare Renal Div II Jul-06-2011
12 Baxter Healthcare Renal Div II May-03-2011
13 Baxter Healthcare Renal Div I Mar-01-2010
14 Baxter Healthcare Renal Div II Mar-07-2008
15 Fresenius Medical Care Holdings, Inc. II Nov-05-2013
16 Fresenius Medical Care Holdings, Inc. II Jul-10-2013
17 Fresenius Medical Care Holdings, Inc. II Feb-11-2013
18 Fresenius Medical Care Holdings, Inc. II Apr-24-2012
19 Fresenius Medical Care Holdings, Inc. II Oct-20-2010
20 Fresenius Medical Care Renal Therapies Group, LLC II Jan-27-2016

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