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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 6131
Device operates differently than expected 3554
Improper or incorrect procedure or method 3114
Fluid leak 2542
No Known Device Problem 2101
Overfill 525
Disconnection 349
Device handling issue 266
Volume accuracy issue 179
Loose or intermittent connection 171
Hole in material 169
No Information 144
Leak 112
Foreign material present in device 96
Air leak 92
Cut in material 68
No code available 56
Component falling 50
Device emits odor 48
Connection issue 48
Use of Device Issue 44
Crack 44
Break 41
Component missing 38
Overheating of device or device component 34
Device alarm system issue 33
Scratched material 28
Degraded 23
Detachment of device component 21
Smoking 17
Fitting problem 17
Grounding malfunction 16
Material integrity issue 14
Material puncture 13
Electrical issue 12
Occlusion within device 10
Ultrafiltration 9
Material rupture 8
Melted 8
Kinked 8
Invalid sensing 8
Detachment of device or device component 7
Noise, Audible 7
Excess flow or overinfusion 7
Contamination during use 7
Inappropriate shock 7
Mechanical issue 6
Filling problem 6
Insufficient heating 5
Material separation 5
Reflux within device 5
Device Difficult to Setup or Prepare 4
Failure to prime 4
Blockage within device or device component 4
Collapse 4
Component(s), broken 4
Human-Device Interface Issue 4
Infusion or flow issue 4
Tear, rip or hole in device packaging 4
Material deformation 4
Dislodged or dislocated 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
Torn material 3
Failure to cycle 3
Not audible alarm 3
Alarm, audible 3
Difficult to insert 3
Fire 3
Misconnection 3
Incorrect or inadequate result 3
Sticking 3
Device inoperable 2
Shipping damage or problem 2
Difficult to remove 2
Nonstandard device or device component 2
Misassembled 2
Incorrect measurement 2
No display or display failure 2
Incorrect display 2
Alarm not visible 2
No flow 2
Manufacturing or shipping issue associated with device 2
Improper flow or infusion 2
Other (for use when an appropriate device code cannot be identified) 2
Defective component 2
Out-of-box failure 2
Inaccurate delivery 2
Expulsion 2
Split 2
Failure to disconnect 2
Defective item 2
Failure to spike 1
Ambient noise issue 1
Battery issue 1
Filtration issue 1
Device sensing issue 1
Total Device Problems 20451

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 0
Class II 0 1 0 1 2 2 3 0 5 3
Class III 0 0 0 0 0 0 0 0 1 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 Renal Div II Aug-02-2012
10 Baxter Healthcare Renal Div II Jul-06-2011
11 Baxter Healthcare Renal Div II May-03-2011
12 Baxter Healthcare Renal Div I Mar-01-2010
13 Baxter Healthcare Renal Div II Mar-07-2008
14 Fresenius Medical Care Holdings, Inc. II Nov-05-2013
15 Fresenius Medical Care Holdings, Inc. II Jul-10-2013
16 Fresenius Medical Care Holdings, Inc. II Feb-11-2013
17 Fresenius Medical Care Holdings, Inc. II Apr-24-2012
18 Fresenius Medical Care Holdings, Inc. II Oct-20-2010
19 Fresenius Medical Care Renal Therapies Group, LLC II Jan-27-2016

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