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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 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 4636 4636
2018 3379 3379
2019 2456 2456
2020 2870 2870
2021 3167 3167
2022 964 964

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9909 9909
Improper or Incorrect Procedure or Method 2099 2099
Fluid Leak 1872 1872
Disconnection 1410 1410
Crack 633 633
Detachment of Device or Device Component 497 497
Break 328 328
Loose or Intermittent Connection 299 299
Product Quality Problem 199 199
Failure to Disconnect 153 153
Connection Problem 139 139
Device Contamination with Chemical or Other Material 123 123
Unsealed Device Packaging 106 106
Fitting Problem 93 93
Difficult to Open or Close 77 77
Component Missing 72 72
Material Puncture/Hole 72 72
Incomplete or Inadequate Connection 63 63
Packaging Problem 53 53
Tear, Rip or Hole in Device Packaging 50 50
Leak/Splash 45 45
Misassembled 44 44
Material Separation 41 41
Material Split, Cut or Torn 39 39
Mechanical Problem 38 38
Device Displays Incorrect Message 36 36
Free or Unrestricted Flow 31 31
Protective Measures Problem 27 27
Delivered as Unsterile Product 27 27
Improper Flow or Infusion 25 25
No Flow 24 24
Device Operates Differently Than Expected 24 24
Hole In Material 24 24
Material Deformation 13 13
Cut In Material 9 9
Device Dislodged or Dislocated 6 6
Radiation Underexposure 5 5
Material Rupture 5 5
Material Perforation 5 5
Defective Component 5 5
Component Misassembled 5 5
Misconnection 4 4
Fracture 4 4
Detachment Of Device Component 3 3
Shipping Damage or Problem 3 3
Mechanical Jam 3 3
Device Packaging Compromised 3 3
Separation Problem 3 3
Insufficient Information 2 2
Expiration Date Error 2 2
Device Markings/Labelling Problem 2 2
Scratched Material 2 2
Material Twisted/Bent 2 2
Use of Device Problem 2 2
Contamination 2 2
Partial Blockage 2 2
Labelling, Instructions for Use or Training Problem 2 2
Kinked 2 2
Difficult to Flush 1 1
Restricted Flow rate 1 1
Complete Blockage 1 1
Device Damaged Prior to Use 1 1
Sticking 1 1
Suction Problem 1 1
Nonstandard Device 1 1
Failure to Prime 1 1
Material Integrity Problem 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Operating System Becomes Nonfunctional 1 1
Expulsion 1 1
Structural Problem 1 1
Separation Failure 1 1
Defective Device 1 1
Overfill 1 1
Obstruction of Flow 1 1
Incomplete or Missing Packaging 1 1
Device Handling Problem 1 1
Positioning Problem 1 1
Air/Gas in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Peritonitis 11458 11458
No Consequences Or Impact To Patient 2668 2668
No Clinical Signs, Symptoms or Conditions 1592 1592
Abdominal Pain 1457 1457
No Patient Involvement 595 595
No Known Impact Or Consequence To Patient 569 569
Unspecified Infection 552 552
Fever 293 293
Vomiting 177 177
Death 173 173
Diarrhea 148 148
Nausea 77 77
Sepsis 69 69
Malaise 68 68
Pain 65 65
Weakness 27 27
Cardiac Arrest 25 25
Low Blood Pressure/ Hypotension 23 23
Inflammation 22 22
Chills 20 20
Septic Shock 14 14
Fatigue 14 14
Abdominal Distention 12 12
Constipation 10 10
Dyspnea 10 10
Discomfort 10 10
Dizziness 8 8
Multiple Organ Failure 7 7
Lethargy 6 6
Edema 6 6
Dehydration 5 5
Cardiopulmonary Arrest 5 5
Hyperthermia 5 5
Injury 5 5
Myocardial Infarction 5 5
Abdominal Cramps 5 5
Insufficient Information 5 5
Decreased Appetite 4 4
Weight Changes 4 4
Rash 4 4
Fungal Infection 4 4
Bacterial Infection 4 4
Headache 3 3
Muscle Weakness 3 3
Distress 3 3
Loss of consciousness 3 3
Electrolyte Imbalance 3 3
Swelling 3 3
Shaking/Tremors 3 3
Confusion/ Disorientation 3 3
Pallor 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Alteration in Body Temperature 2 2
Tachycardia 2 2
Thyroid Problems 2 2
Cramp(s) 2 2
Burning Sensation 2 2
Itching Sensation 2 2
Dysphagia/ Odynophagia 2 2
Hyperplasia 2 2
Hypersensitivity/Allergic reaction 2 2
High Blood Pressure/ Hypertension 2 2
Stroke/CVA 2 2
Chest Pain 2 2
Fainting 2 2
Fall 2 2
Encephalopathy 1 1
Purulent Discharge 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Syncope 1 1
Abscess 1 1
Arrhythmia 1 1
Hypoglycemia 1 1
Hemorrhage/Bleeding 1 1
Muscle Spasm(s) 1 1
Necrosis 1 1
Immunodeficiency 1 1
Peritoneal Laceration(s) 1 1
Pleural Effusion 1 1
Shock 1 1
Suffocation 1 1
Dermatomyositis 1 1
Cardiogenic Shock 1 1
Discharge 1 1
Myalgia 1 1
Viral Infection 1 1
Sweating 1 1
Chest Tightness/Pressure 1 1
Sore Throat 1 1
Reaction 1 1
No Information 1 1
Low Oxygen Saturation 1 1
Ambulation Difficulties 1 1
Loss Of Pulse 1 1
Thromboembolism 1 1
Nervous System Injury 1 1
Spinal Arachnoiditis 1 1
Cough 1 1
Respiratory Arrest 1 1
Hyponatremia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-29-2022
2 Baxter Healthcare Corporation II Feb-08-2022
3 Baxter Healthcare Corporation II Jan-04-2021
4 Baxter Healthcare Corporation II Jun-02-2017
5 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
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