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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 8500
Device Displays Incorrect Message 6746
Adverse Event Without Identified Device or Use Problem 5229
Device Operates Differently Than Expected 3837
Improper or Incorrect Procedure or Method 3242
Thermal Decomposition of Device 1790
Overfill 1096
Connector 968
Tube 824
Disconnection 811
Loose or Intermittent Connection 522
Cassette 456
Device Handling Problem 358
Device Contamination with Chemical or Other Material 223
Volume Accuracy Problem 219
Hole In Material 200
Improper Flow or Infusion 179
Cap 141
Protective Measures Problem 140
Overheating of Device 105
Cut In Material 101
Break 99
Component Missing 94
Crack 89
Insufficient Information 85
Leak / Splash 76
Connection Problem 75
Material Puncture / Hole 75
Bags 68
Device Emits Odor 50
Material Split, Cut or Torn 45
Smoking 43
Grounding Malfunction 41
Use of Device Problem 40
Sparking 35
Device Alarm System 32
Fitting Problem 32
Device Issue 24
Degraded 23
Barrier 22
Electrical /Electronic Property Problem 21
Air Leak 20
Detachment of Device or device Component 19
Melted 19
Material Integrity Problem 15
Scratched Material 14
Misassembled 13
Clamp 13
Material Rupture 12
Material Deformation 12
Material Perforation 12
Port 10
Filling Problem 9
Tear, Rip or Hole in Device Packaging 9
Membrane 9
Seal 9
Kinked 9
Invalid Sensing 8
Noise, Audible 8
Occlusion Within Device 8
Bent 8
Detachment Of Device Component 7
Mechanical Problem 7
Inappropriate Shock 7
Temperature Problem 6
Fire 6
Reflux within Device 5
Appropriate Term/Code Not Available 5
Incomplete or Inadequate Connection 5
Failure to Disconnect 5
Absorber 5
Housing 5
Insufficient Heating 5
Image Display Error / Artifact 5
Incorrect, Inadequate or Imprecise Result or Readings 4
Plug 4
Partial Blockage 4
Device Inoperable 4
Delivery System Issue, No Description 3
Electrical Shorting 3
Device Operational Issue 3
Misconnection 3
Torn Material 3
Power Problem 2
Delivered as Unsterile Product 2
Material Separation 2
Product Quality Problem 2
Device Dislodged or Dislocated 2
Incorrect Measurement 2
Power Cord 2
Inadequate Ultra Filtration 2
Device Contamination with Body Fluid 2
Locking Sleeve 2
Foil 2
Failure to Cycle 2
No Display / Image 2
Arcing 2
Contamination During Use 2
No Audible Alarm 2
Alarm, failure of warning 1
Total Device Problems 37129

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 Oct-03-2019
11 Baxter Healthcare Corporation II Feb-20-2019
12 Baxter Healthcare Corporation II Aug-02-2018
13 Baxter Healthcare Corporation II Aug-16-2017
14 Baxter Healthcare Corporation II Jan-19-2017
15 Fresenius Medical Care Renal Therapies Group, LLC II Aug-05-2019
16 Fresenius Medical Care Renal Therapies Group, LLC II Apr-12-2018
17 Fresenius Medical Care Renal Therapies Group, LLC II Jan-27-2016

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