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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 6765
Device Displays Incorrect Message 6685
Adverse Event Without Identified Device or Use Problem 4460
Device Operates Differently Than Expected 3837
Improper or Incorrect Procedure or Method 3223
Overfill 944
Connector 766
Thermal Decomposition of Device 725
Disconnection 674
Tube 631
Loose or Intermittent Connection 434
Cassette 406
Device Handling Problem 356
Volume Accuracy Problem 219
Device Contamination with Chemical or Other Material 205
Hole In Material 200
Overheating of Device 105
Cap 104
Cut In Material 101
Improper Flow or Infusion 90
Break 89
Insufficient Information 85
Component Missing 85
Leak / Splash 76
Crack 75
Connection Problem 69
Device Emits Odor 49
Bags 44
Use of Device Problem 40
Grounding Malfunction 40
Smoking 36
Material Puncture / Hole 32
Device Alarm System 32
Fitting Problem 29
Material Split, Cut or Torn 25
Sparking 25
Device Issue 24
Degraded 23
Barrier 22
Electrical /Electronic Property Problem 21
Air Leak 20
Melted 16
Material Integrity Problem 14
Misassembled 13
Material Perforation 12
Clamp 11
Material Deformation 10
Filling Problem 9
Kinked 9
Material Rupture 9
Tear, Rip or Hole in Device Packaging 9
Bent 8
Occlusion Within Device 8
Invalid Sensing 8
Noise, Audible 8
Detachment of Device or device Component 8
Mechanical Problem 7
Detachment Of Device Component 7
Inappropriate Shock 7
Temperature Problem 6
Membrane 5
Housing 5
Failure to Disconnect 5
Scratched Material 5
Image Display Error / Artifact 5
Reflux within Device 5
Absorber 5
Insufficient Heating 5
Appropriate Term/Code Not Available 5
Port 4
Device Inoperable 4
Fire 4
Plug 4
Partial Blockage 4
Incorrect, Inadequate or Imprecise Result or Readings 4
Torn Material 3
Electrical Shorting 3
Delivery System Issue, No Description 3
Device Operational Issue 3
Misconnection 3
Contamination During Use 2
Inadequate Ultra Filtration 2
Power Problem 2
Device Contamination with Body Fluid 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
Spring Loading Mechanism 1
Ambient Noise Problem 1
Moisture Damage 1
Heat Exchanger 1
Total Device Problems 32167

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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