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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 914 914

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7375 7375
Fluid/Blood Leak 2159 2159
Improper or Incorrect Procedure or Method 1588 1588
Disconnection 1505 1505
Detachment of Device or Device Component 977 977
Crack 547 547
Break 318 318
Loose or Intermittent Connection 262 262
Failure to Disconnect 254 254
Product Quality Problem 201 201
Difficult to Open or Close 194 194
Connection Problem 176 176
Incomplete or Inadequate Connection 135 135
Fitting Problem 134 134
Material Puncture/Hole 103 103
Free or Unrestricted Flow 90 90
Unsealed Device Packaging 89 89
Device Contamination with Chemical or Other Material 74 74
Tear, Rip or Hole in Device Packaging 61 61
Protective Measures Problem 50 50
Component Missing 48 48
Leak/Splash 42 42
Material Separation 41 41
Material Split, Cut or Torn 40 40
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 10 10
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
Use of Device Problem 5 5
Noise, Audible 5 5
Air/Gas in Device 5 5
Device Damaged Prior to Use 4 4
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 8530 8530
No Clinical Signs, Symptoms or Conditions 3983 3983
No Consequences Or Impact To Patient 1520 1520
Abdominal Pain 1468 1468
Unspecified Infection 609 609
No Known Impact Or Consequence To Patient 314 314
No Patient Involvement 294 294
Fever 278 278
Vomiting 173 173
Diarrhea 140 140
Death 92 92
Pain 73 73
Nausea 69 69
Malaise 61 61
Sepsis 48 48
Low Blood Pressure/ Hypotension 33 33
Cardiac Arrest 32 32
Fatigue 28 28
Decreased Appetite 27 27
Chills 21 21
Insufficient Information 20 20
Constipation 18 18
Muscle Weakness 17 17
Dyspnea 15 15
Septic Shock 14 14
Abdominal Distention 14 14
Discomfort 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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