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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 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 343 387
Insufficient Information 172 172
Use of Device Problem 33 33
No Apparent Adverse Event 28 28
Patient-Device Incompatibility 27 27
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
Output Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Appropriate Term/Code Not Available 6 6
Leak/Splash 6 6
Excess Flow or Over-Infusion 5 5
Misassembled 5 5
Device Alarm System 5 5
Break 5 5
Improper Flow or Infusion 5 5
Defective Device 5 5
Material Discolored 4 4
Defective Component 4 4
Coagulation in Device or Device Ingredient 3 3
Device Handling Problem 3 3
Component Misassembled 2 2
Air/Gas in Device 2 2
Expiration Date Error 2 2
Pumping Problem 2 2
Device Slipped 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Microbial Contamination of Device 2 2
Contamination /Decontamination Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Display or Visual Feedback Problem 2 2
Inaccurate Flow Rate 2 2
Backflow 2 2
Off-Label Use 2 2
Mechanical Problem 2 2
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
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
High Test Results 1 1
Structural Problem 1 1
Volume Accuracy Problem 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Self-Activation or Keying 1 1
Inadequate User Interface 1 1
Pressure Problem 1 1
Protective Measures Problem 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
Priming Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
No Known Impact Or Consequence To Patient 57 57
Reaction 44 44
Insufficient Information 39 39
Low Blood Pressure/ Hypotension 36 58
Hemolysis 34 34
Death 34 34
Hypersensitivity/Allergic reaction 25 47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 41
Itching Sensation 18 18
Rash 17 17
Hypervolemia 12 12
Local Reaction 11 11
Tachycardia 11 11
Dyspnea 11 11
Air Embolism 11 11
Nausea 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
Bacterial Infection 6 6
Anemia 6 6
Hematoma 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
Pain 4 4
Pulmonary Embolism 4 4
Diarrhea 4 13
Erythema 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
Headache 2 2
Arrhythmia 2 2
Paralysis 2 2
Inflammation 2 2
Hypovolemic Shock 2 2
Hypothermia 1 1
Hyperthermia 1 1
Hyperbilirubinemia 1 1
Ischemia 1 1
Muscular Rigidity 1 1
Pulmonary Edema 1 1
Overdose 1 1
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
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
Muscle Hypotonia 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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