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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
FRESENIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Fluid Leak 7207
Device Displays Incorrect Message 6746
Adverse Event Without Identified Device or Use Problem 4628
Device Operates Differently Than Expected 3837
Improper or Incorrect Procedure or Method 3229
Thermal Decomposition of Device 1136
Overfill 987
Connector 832
Disconnection 725
Tube 673
Loose or Intermittent Connection 460
Cassette 421
Device Handling Problem 356
Volume Accuracy Problem 219
Device Contamination with Chemical or Other Material 209
Hole In Material 200
Cap 112
Improper Flow or Infusion 106
Overheating of Device 105
Cut In Material 101
Break 92
Component Missing 86
Insufficient Information 85
Crack 81
Leak / Splash 76
Connection Problem 71
Device Emits Odor 49
Bags 48
Material Puncture / Hole 44
Grounding Malfunction 41
Use of Device Problem 40
Smoking 39
Device Alarm System 32
Fitting Problem 30
Sparking 28
Material Split, Cut or Torn 27
Device Issue 24
Degraded 23
Barrier 22
Electrical /Electronic Property Problem 21
Air Leak 20
Melted 17
Material Integrity Problem 14
Misassembled 13
Material Rupture 12
Material Perforation 12
Detachment of Device or device Component 11
Clamp 11
Material Deformation 10
Filling Problem 9
Kinked 9
Tear, Rip or Hole in Device Packaging 9
Bent 8
Occlusion Within Device 8
Invalid Sensing 8
Membrane 8
Noise, Audible 8
Mechanical Problem 7
Scratched Material 7
Detachment Of Device Component 7
Inappropriate Shock 7
Temperature Problem 6
Failure to Disconnect 5
Housing 5
Image Display Error / Artifact 5
Reflux within Device 5
Protective Measures Problem 5
Absorber 5
Insufficient Heating 5
Appropriate Term/Code Not Available 5
Device Inoperable 4
Port 4
Fire 4
Plug 4
Partial Blockage 4
Incorrect, Inadequate or Imprecise Result or Readings 4
Torn Material 3
Electrical Shorting 3
Incomplete or Inadequate Connection 3
Delivery System Issue, No Description 3
Device Operational Issue 3
Misconnection 3
Contamination During Use 2
Inadequate Ultra Filtration 2
Device Contamination with Body Fluid 2
Power Problem 2
Failure to Cycle 2
No Display / Image 2
Incorrect Measurement 2
No Audible Alarm 2
Device Dislodged or Dislocated 2
Power Cord 2
Material Separation 2
Foil 2
Locking Sleeve 2
Automatic injection system overinfusion 1
Difficult to Insert 1
Restricted Flow rate 1
Moisture Damage 1
Ambient Noise Problem 1
Total Device Problems 33582

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp II Sep-14-2017
2 Baxter Healthcare Corp. II Aug-22-2016
3 Baxter Healthcare Corp. II Apr-25-2016
4 Baxter Healthcare Corp. III Nov-17-2015
5 Baxter Healthcare Corp. II Mar-18-2015
6 Baxter Healthcare Corp. II Feb-02-2015
7 Baxter Healthcare Corp. II Jan-29-2015
8 Baxter Healthcare Corp. II Jan-07-2015
9 Baxter Healthcare Corp. II Jan-07-2015
10 Baxter Healthcare Corporation II Feb-20-2019
11 Baxter Healthcare Corporation II Aug-02-2018
12 Baxter Healthcare Corporation II Aug-16-2017
13 Baxter Healthcare Corporation II Jan-19-2017
14 Fresenius Medical Care Renal Therapies Group, LLC II Apr-12-2018
15 Fresenius Medical Care Renal Therapies Group, LLC II Jan-27-2016

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