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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 132 132
2024 145 145

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 417 461
Insufficient Information 282 282
No Apparent Adverse Event 56 56
Use of Device Problem 34 34
Patient-Device Incompatibility 27 27
Improper or Incorrect Procedure or Method 16 16
Fluid/Blood Leak 16 16
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
Therapeutic or Diagnostic Output Failure 6 6
Output Problem 6 6
Leak/Splash 6 6
Defective Device 5 5
Device Alarm System 5 5
Inadequate User Interface 5 5
Improper Flow or Infusion 5 5
Excess Flow or Over-Infusion 5 5
Break 5 5
Misassembled 5 5
Device Handling Problem 5 5
Defective Component 4 4
Material Discolored 4 4
Mechanical Problem 4 4
Device Slipped 4 4
Coagulation in Device or Device Ingredient 3 3
Pumping Problem 2 2
Expiration Date Error 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Microbial Contamination of Device 2 2
Contamination /Decontamination Problem 2 2
Display or Visual Feedback Problem 2 2
Air/Gas in Device 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Backflow 2 2
Off-Label Use 2 2
Inaccurate Flow Rate 2 2
Contamination of Device Ingredient or Reagent 2 2
Human-Device Interface Problem 2 2
Component Misassembled 2 2
No Flow 1 1
Improper Chemical Reaction 1 1
Loss of or Failure to Bond 1 1
Difficult to Open or Close 1 1
Noise, Audible 1 1
Self-Activation or Keying 1 1
Priming Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 127 127
Low Blood Pressure/ Hypotension 61 83
No Known Impact Or Consequence To Patient 57 57
Reaction 44 44
Hemolysis 42 42
Insufficient Information 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 57
Death 34 34
Hypersensitivity/Allergic reaction 33 55
Itching Sensation 20 20
Rash 19 19
Tachycardia 17 17
Dyspnea 16 16
Hypervolemia 16 16
Local Reaction 15 15
Vomiting 14 23
Nausea 14 14
Fever 13 13
Air Embolism 13 13
Anemia 12 12
Chest Pain 12 12
Urticaria 11 11
Paresthesia 11 20
Syncope/Fainting 10 10
Dizziness 9 9
Electrolyte Imbalance 9 31
No Consequences Or Impact To Patient 9 9
Sepsis 9 22
Hemorrhage/Bleeding 9 9
High Blood Pressure/ Hypertension 8 8
Cardiac Arrest 8 8
Thrombocytopenia 8 8
Blood Loss 8 8
Bacterial Infection 7 7
Hematoma 7 7
Unspecified Infection 7 29
Pulmonary Embolism 5 5
Diarrhea 5 14
Pain 5 5
Numbness 5 5
Hypovolemia 5 5
No Patient Involvement 5 5
Heart Failure/Congestive Heart Failure 5 5
Liver Failure 5 5
Swelling/ Edema 5 5
Cramp(s) /Muscle Spasm(s) 4 4
No Information 4 4
Chills 4 4
Erythema 4 4
Arrhythmia 3 3

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