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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device separator, automated, blood cell and plasma, therapeutic
Product CodeLKN
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 72 72
2020 135 135
2021 63 107
2022 42 42
2023 131 131
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 324 368
Insufficient Information 153 153
Use of Device Problem 31 31
Patient-Device Incompatibility 27 27
No Apparent Adverse Event 24 24
Fluid/Blood Leak 16 16
Improper or Incorrect Procedure or Method 14 14
Gas/Air Leak 12 12
Device Displays Incorrect Message 10 10
Insufficient Flow or Under Infusion 8 8
Obstruction of Flow 8 8
Infusion or Flow Problem 7 7
Appropriate Term/Code Not Available 6 6
Output Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Leak/Splash 6 6
Misassembled 5 5
Excess Flow or Over-Infusion 5 5
Device Alarm System 5 5
Break 5 5
Defective Device 5 5
Improper Flow or Infusion 5 5
Defective Component 4 4
Material Discolored 4 4
Coagulation in Device or Device Ingredient 3 3
Device Handling Problem 3 3
Pumping Problem 2 2
Component Misassembled 2 2
Air/Gas in Device 2 2
Expiration Date Error 2 2
Contamination /Decontamination Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Microbial Contamination of Device 2 2
Display or Visual Feedback Problem 2 2
Inaccurate Flow Rate 2 2
Backflow 2 2
Off-Label Use 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Self-Activation or Keying 1 1
Material Puncture/Hole 1 1
Reflux within Device 1 1
Nonstandard Device 1 1
Loss of or Failure to Bond 1 1
No Audible Alarm 1 1
Alarm Not Visible 1 1
Complete Blockage 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
High Test Results 1 1
Structural Problem 1 1
Volume Accuracy Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Open or Close 1 1
Free or Unrestricted Flow 1 1
Priming Problem 1 1
Noise, Audible 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Inadequate User Interface 1 1
Improper Chemical Reaction 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72 72
No Known Impact Or Consequence To Patient 57 57
Reaction 44 44
Death 34 34
Insufficient Information 34 34
Low Blood Pressure/ Hypotension 33 55
Hemolysis 32 32
Hypersensitivity/Allergic reaction 24 46
Itching Sensation 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 40
Rash 17 17
Local Reaction 11 11
Tachycardia 11 11
Dyspnea 11 11
Air Embolism 10 10
Nausea 10 10
Hypervolemia 10 10
Fever 9 9
Chest Pain 9 9
Vomiting 9 18
Electrolyte Imbalance 9 31
No Consequences Or Impact To Patient 9 9
Blood Loss 8 8
Sepsis 8 21
Cardiac Arrest 8 8
Paresthesia 8 17
Hemorrhage/Bleeding 7 7
High Blood Pressure/ Hypertension 6 6
Unspecified Infection 6 28
Anemia 6 6
Bacterial Infection 5 5
Dizziness 5 5
No Patient Involvement 5 5
Thrombocytopenia 5 5
Syncope/Fainting 5 5
Heart Failure/Congestive Heart Failure 5 5
Liver Failure 5 5
Cramp(s) /Muscle Spasm(s) 4 4
No Information 4 4
Numbness 4 4
Urticaria 4 4
Pulmonary Embolism 4 4
Diarrhea 4 13
Erythema 4 4
Pain 4 4
Hematoma 4 4
Anxiety 3 3
Hypoxia 3 3
Hypovolemia 3 3
Chest Tightness/Pressure 3 3
Low Oxygen Saturation 3 3
Cough 3 3
Swelling/ Edema 3 3
Unspecified Respiratory Problem 2 2
Unspecified Heart Problem 2 2
Pallor 2 2
Sweating 2 2
Loss of consciousness 2 2
Discomfort 2 2
Malaise 2 2
Hypovolemic Shock 2 2
Paralysis 2 2
Inflammation 2 2
Headache 2 2
Arrhythmia 2 2
Atrial Fibrillation 1 1
Autoimmune Disorder 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Cardiomyopathy 1 1
Stroke/CVA 1 1
Hearing Impairment 1 1
Ischemia 1 1
Muscular Rigidity 1 1
Pulmonary Edema 1 1
Overdose 1 1
Hypothermia 1 1
Hyperthermia 1 1
Hyperbilirubinemia 1 1
Sore Throat 1 1
Hot Flashes/Flushes 1 1
Chills 1 1
Shock 1 1
Thrombosis 1 1
Respiratory Distress 1 1
Seizures 1 1
Encephalitis 1 1
Diaphoresis 1 1
Respiratory Failure 1 1
Increased Respiratory Rate 1 1
Cognitive Changes 1 1
Hematuria 1 1
Loss Of Pulse 1 1
Movement Disorder 1 1
Wheezing 1 1
Convulsion/Seizure 1 1
Presyncope 1 1
Low White Blood Cell Count 1 1
Thrombosis/Thrombus 1 1
Nodule 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fenwal Inc II Mar-15-2023
2 Fenwal Inc II Apr-02-2021
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