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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
Product CodeKDJ
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2456 2456
2020 2870 2870
2021 3167 3167
2022 2927 2927
2023 2947 2947
2024 1171 1171

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7477 7477
Fluid/Blood Leak 2194 2194
Improper or Incorrect Procedure or Method 1605 1605
Disconnection 1512 1512
Detachment of Device or Device Component 1040 1040
Crack 555 555
Break 321 321
Failure to Disconnect 272 272
Loose or Intermittent Connection 263 263
Product Quality Problem 202 202
Difficult to Open or Close 202 202
Connection Problem 176 176
Incomplete or Inadequate Connection 137 137
Fitting Problem 135 135
Material Puncture/Hole 103 103
Unsealed Device Packaging 90 90
Free or Unrestricted Flow 90 90
Device Contamination with Chemical or Other Material 76 76
Tear, Rip or Hole in Device Packaging 62 62
Protective Measures Problem 51 51
Component Missing 49 49
Leak/Splash 45 45
Material Separation 41 41
Material Split, Cut or Torn 41 41
Nonstandard Device 37 37
Mechanical Problem 34 34
Delivered as Unsterile Product 31 31
No Flow 28 28
Packaging Problem 24 24
Improper Flow or Infusion 11 11
Material Deformation 11 11
Defective Component 8 8
Component Misassembled 7 7
Material Rupture 6 6
Fracture 6 6
Device Dislodged or Dislocated 6 6
Device Displays Incorrect Message 5 5
Device Damaged Prior to Use 5 5
Use of Device Problem 5 5
Noise, Audible 5 5
Air/Gas in Device 5 5
Shipping Damage or Problem 4 4
Material Disintegration 4 4
Scratched Material 4 4
Unintended Movement 3 3
Material Integrity Problem 3 3
Mechanical Jam 3 3
Contamination /Decontamination Problem 3 3
Complete Blockage 3 3
Contamination 3 3
Misconnection 3 3
Material Perforation 3 3
Separation Problem 3 3
Migration 3 3
Device Slipped 2 2
Partial Blockage 2 2
Melted 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Twisted/Bent 2 2
Separation Failure 2 2
Defective Device 2 2
Incomplete or Missing Packaging 2 2
Structural Problem 1 1
Malposition of Device 1 1
Expulsion 1 1
Difficult to Open or Remove Packaging Material 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Markings/Labelling Problem 1 1
Naturally Worn 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
Positioning Problem 1 1
Operating System Becomes Nonfunctional 1 1
Misassembled 1 1
Labelling, Instructions for Use or Training Problem 1 1
Backflow 1 1
Difficult to Flush 1 1
Insufficient Flow or Under Infusion 1 1
Thickening of Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Peritonitis 8646 8646
No Clinical Signs, Symptoms or Conditions 4118 4118
No Consequences Or Impact To Patient 1520 1520
Abdominal Pain 1496 1496
Unspecified Infection 613 613
No Known Impact Or Consequence To Patient 314 314
No Patient Involvement 294 294
Fever 280 280
Vomiting 174 174
Diarrhea 140 140
Death 92 92
Pain 73 73
Nausea 70 70
Malaise 62 62
Sepsis 49 49
Low Blood Pressure/ Hypotension 33 33
Cardiac Arrest 32 32
Fatigue 29 29
Decreased Appetite 28 28
Insufficient Information 22 22
Chills 21 21
Constipation 18 18
Muscle Weakness 17 17
Abdominal Distention 15 15
Discomfort 15 15
Dyspnea 15 15
Septic Shock 14 14
Weakness 11 11
Dizziness 11 11
Inflammation 11 11
Cramp(s) /Muscle Spasm(s) 10 10
Lethargy 10 10
Swelling/ Edema 7 7
Bacterial Infection 7 7
Hyperthermia 6 6
Fungal Infection 6 6
Headache 5 5
Edema 4 4
Cardiopulmonary Arrest 4 4
Confusion/ Disorientation 4 4
Loss of consciousness 3 3
Weight Changes 3 3
Electrolyte Imbalance 3 3
Myocardial Infarction 3 3
Hypersensitivity/Allergic reaction 3 3
High Blood Pressure/ Hypertension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Alteration in Body Temperature 3 3
Unspecified Tissue Injury 2 2
Itching Sensation 2 2
Hyperplasia 2 2
Fall 2 2
Stroke/CVA 2 2
Chest Pain 2 2
Dehydration 2 2
Purulent Discharge 2 2
Dysphagia/ Odynophagia 2 2
Rash 2 2
Cramp(s) 2 2
Shaking/Tremors 2 2
Abdominal Cramps 2 2
Ambulation Difficulties 2 2
Diaphoresis 2 2
Pallor 2 2
Distress 2 2
Dermatomyositis 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Sore Throat 1 1
Numbness 1 1
Burning Sensation 1 1
Myalgia 1 1
Viral Infection 1 1
Swelling 1 1
Peritoneal Laceration(s) 1 1
Syncope 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Bradycardia 1 1
Cyanosis 1 1
Abscess 1 1
Arrhythmia 1 1
Autoimmune Disorder 1 1
Pyrosis/Heartburn 1 1
Encephalopathy 1 1
Cardiac Enzyme Elevation 1 1
Fainting 1 1
Hypoglycemia 1 1
Implant Pain 1 1
Thromboembolism 1 1
Nervous System Injury 1 1
No Information 1 1
Multiple Organ Failure 1 1
Syncope/Fainting 1 1
Spinal Arachnoiditis 1 1
Ischemia Stroke 1 1
Heart Failure/Congestive Heart Failure 1 1
Cough 1 1
Respiratory Arrest 1 1
Hematemesis 1 1
Hyponatremia 1 1

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