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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, administration, for peritoneal dialysis, disposable
Regulation Description Peritoneal dialysis system and accessories.
Product CodeKDJ
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2870 2870
2021 3167 3167
2022 2927 2927
2023 2947 2947
2024 3114 3114
2025 246 246

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6783 6783
Fluid/Blood Leak 2168 2168
Detachment of Device or Device Component 1623 1623
Disconnection 1471 1471
Improper or Incorrect Procedure or Method 1470 1470
Crack 575 575
Failure to Disconnect 368 368
Break 337 337
Difficult to Open or Close 263 263
Loose or Intermittent Connection 216 216
Product Quality Problem 192 192
Connection Problem 145 145
Incomplete or Inadequate Connection 134 134
Fitting Problem 122 122
Free or Unrestricted Flow 103 103
Unsealed Device Packaging 98 98
Material Puncture/Hole 91 91
Device Contamination with Chemical or Other Material 78 78
Tear, Rip or Hole in Device Packaging 64 64
Protective Measures Problem 59 59
Leak/Splash 53 53
Component Missing 50 50
No Flow 44 44
Material Separation 41 41
Nonstandard Device 37 37
Material Split, Cut or Torn 34 34
Delivered as Unsterile Product 29 29
Packaging Problem 20 20
Mechanical Problem 12 12
Material Deformation 11 11
Defective Component 10 10
Material Rupture 8 8
Fracture 7 7
Improper Flow or Infusion 7 7
Air/Gas in Device 7 7
Component Misassembled 7 7
Material Perforation 7 7
Device Dislodged or Dislocated 6 6
Device Damaged Prior to Use 5 5
Noise, Audible 5 5
Material Disintegration 4 4
Scratched Material 4 4
Unintended Movement 4 4
Use of Device Problem 4 4
Misconnection 4 4
Shipping Damage or Problem 4 4
Mechanical Jam 3 3
Contamination /Decontamination Problem 3 3
Migration 3 3
Separation Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Peritonitis 7904 7904
No Clinical Signs, Symptoms or Conditions 5416 5416
Abdominal Pain 1527 1527
No Consequences Or Impact To Patient 952 952
Unspecified Infection 581 581
No Known Impact Or Consequence To Patient 271 271
Fever 245 245
Vomiting 186 186
Diarrhea 132 132
No Patient Involvement 128 128
Nausea 73 73
Pain 67 67
Death 66 66
Malaise 61 61
Sepsis 50 50
Low Blood Pressure/ Hypotension 38 38
Decreased Appetite 33 33
Fatigue 32 32
Cardiac Arrest 30 30
Chills 25 25
Insufficient Information 25 25
Constipation 21 21
Abdominal Distention 20 20
Muscle Weakness 19 19
Swelling/ Edema 17 17
Dyspnea 15 15
Septic Shock 15 15
Cramp(s) /Muscle Spasm(s) 14 14
Discomfort 12 12
Lethargy 11 11
Dizziness 10 10
Bacterial Infection 9 9
Inflammation 8 8
Abdominal Cramps 6 6
Hyperthermia 6 6
Weakness 5 5
Confusion/ Disorientation 4 4
Headache 4 4
High Blood Pressure/ Hypertension 4 4
Myocardial Infarction 4 4
Fungal Infection 4 4
Chest Pain 4 4
Electrolyte Imbalance 4 4
Hypersensitivity/Allergic reaction 3 3
Alteration in Body Temperature 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Stroke/CVA 3 3
Cardiopulmonary Arrest 3 3
Weight Changes 3 3
Cough 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Nov-27-2024
2 Baxter Healthcare Corporation I Nov-20-2024
3 Baxter Healthcare Corporation II Mar-03-2023
4 Baxter Healthcare Corporation II May-27-2022
5 Baxter Healthcare Corporation II Mar-29-2022
6 Baxter Healthcare Corporation II Feb-08-2022
7 Baxter Healthcare Corporation II Jan-04-2021
8 Fresenius Medical Care Holdings, Inc. I Mar-26-2024
9 Fresenius Medical Care Holdings, Inc. II Dec-07-2023
10 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
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