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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
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CLOUDCATH
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 2
IREN-MEDICAL, LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4598 4598
2021 5076 5076
2022 4503 4503
2023 3913 3913
2024 3772 3772
2025 262 262

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 10476 10476
Adverse Event Without Identified Device or Use Problem 5658 5658
Thermal Decomposition of Device 2690 2690
Protective Measures Problem 979 979
Disconnection 672 672
Overfill 546 546
Loose or Intermittent Connection 399 399
Air/Gas in Device 291 291
Detachment of Device or Device Component 253 253
Failure to Disconnect 231 231
Device Contamination with Chemical or Other Material 219 219
Material Puncture/Hole 208 208
Material Split, Cut or Torn 196 196
Component Missing 165 165
Improper Flow or Infusion 130 130
Break 113 113
Crack 102 102
Improper or Incorrect Procedure or Method 96 96
Sparking 78 78
Fitting Problem 73 73
Incomplete or Inadequate Connection 70 70
Unintended Electrical Shock 36 36
Smoking 32 32
Connection Problem 31 31
Scratched Material 28 28
Output Problem 27 27
Melted 23 23
Material Separation 16 16
Material Twisted/Bent 14 14
Material Deformation 12 12
Material Rupture 11 11
Excessive Heating 9 9
Component Misassembled 9 9
Obstruction of Flow 8 8
Fire 7 7
Leak/Splash 7 7
Malposition of Device 5 5
Insufficient Information 5 5
Therapeutic or Diagnostic Output Failure 5 5
Misconnection 4 4
Positioning Problem 4 4
Noise, Audible 4 4
Material Integrity Problem 3 3
Material Perforation 3 3
Defective Component 3 3
Defective Device 3 3
Contamination 3 3
Intermittent Shock/Stimulation 3 3
Filling Problem 3 3
Gas/Air Leak 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11734 11734
Peritonitis 3732 3732
No Known Impact Or Consequence To Patient 2870 2870
Abdominal Pain 1988 1988
No Consequences Or Impact To Patient 1064 1064
Unspecified Infection 510 510
Insufficient Information 418 418
Increased Intra-Peritoneal Volume (IIPV) 368 368
Dyspnea 304 304
Hernia 242 242
No Patient Involvement 234 234
Nausea 214 214
Hypervolemia 187 187
Vomiting 166 166
Abdominal Distention 151 151
Cardiac Arrest 148 148
Death 120 120
Fever 114 114
Pain 110 110
Diarrhea 90 90
No Information 71 71
Low Blood Pressure/ Hypotension 68 68
Fungal Infection 67 67
Malaise 65 65
Sepsis 60 60
Swelling/ Edema 58 58
Constipation 56 56
Confusion/ Disorientation 50 50
Chest Pain 49 49
Pulmonary Edema 45 45
Myocardial Infarction 43 43
Fatigue 42 42
Discomfort 37 37
Pneumonia 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Electrolyte Imbalance 29 29
High Blood Pressure/ Hypertension 27 27
Pleural Effusion 27 27
Heart Failure/Congestive Heart Failure 23 23
Dizziness 23 23
Loss of consciousness 22 22
Respiratory Failure 20 20
Hypoglycemia 19 19
Fall 18 18
Cramp(s) /Muscle Spasm(s) 18 18
Chills 17 17
Lethargy 17 17
Weakness 17 17
Stroke/CVA 17 17
Hypoxia 16 16

Recalls
Manufacturer Recall Class Date Posted
1 BAXTER HEALTHCARE CORPORATION II Aug-02-2021
2 Baxter Healthcare Corporation II Dec-14-2023
3 Baxter Healthcare Corporation II Apr-01-2023
4 Baxter Healthcare Corporation II May-27-2022
5 Fresenius Medical Care Holdings, Inc. III Dec-26-2023
6 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
7 Fresenius Medical Care Holdings, Inc. II Nov-07-2020
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