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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
CARIDIANBCT, INC.
  SUBSTANTIALLY EQUIVALENT 2
FENWAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI USA LLC
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO BCT, INC..
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 128 128
2015 306 306
2016 206 206
2017 169 169
2018 55 55
2019 72 72
2020 135 135
2021 63 107
2022 42 42
2023 131 131
2024 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 527 571
Insufficient Information 261 261
Inadequate User Interface 158 158
Device Displays Incorrect Message 133 133
Data Problem 126 126
Improper or Incorrect Procedure or Method 110 110
Patient Data Problem 103 103
Use of Device Problem 92 92
Excess Flow or Over-Infusion 50 50
Fluid/Blood Leak 48 48
Nonstandard Device 48 48
Patient-Device Incompatibility 47 47
Device Operates Differently Than Expected 40 40
Incorrect Software Programming Calculations 38 38
No Apparent Adverse Event 33 33
Air Leak 26 26
Leak/Splash 18 18
Device Operational Issue 17 17
Programming Issue 16 16
Occlusion Within Device 15 15
Insufficient Flow or Under Infusion 13 13
Device Alarm System 13 13
Gas/Air Leak 12 12
Obstruction of Flow 12 12
Infusion or Flow Problem 11 11
Improper Flow or Infusion 11 11
Appropriate Term/Code Not Available 10 10
Break 10 10
Misassembled 10 10
Coagulation in Device or Device Ingredient 8 8
High Test Results 8 8
Contamination of Device Ingredient or Reagent 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Output Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Defective Device 6 6
Defective Component 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Component Falling 5 5
Use of Incorrect Control/Treatment Settings 5 5
Material Discolored 5 5
Disconnection 5 5
Human-Device Interface Problem 5 5
Noise, Audible 5 5
Device Handling Problem 4 4
Pressure Problem 4 4
Incorrect Or Inadequate Test Results 4 4
Device Disinfection Or Sterilization Issue 4 4
Display or Visual Feedback Problem 4 4
Clumping in Device or Device Ingredient 4 4
Detachment Of Device Component 4 4
Microbial Contamination of Device 4 4
Unexpected Therapeutic Results 3 3
Device Slipped 3 3
Contamination 3 3
Complete Blockage 3 3
False Reading From Device Non-Compliance 3 3
Contamination /Decontamination Problem 3 3
Expiration Date Error 3 3
Device Contamination with Chemical or Other Material 3 3
Torn Material 3 3
Pumping Problem 2 2
No Flow 2 2
Material Deformation 2 2
Material Twisted/Bent 2 2
Air/Gas in Device 2 2
Component Misassembled 2 2
Misassembly by Users 2 2
Difficult to Open or Close 2 2
Inaccurate Delivery 2 2
Detachment of Device or Device Component 2 2
Inaccurate Flow Rate 2 2
Loose or Intermittent Connection 2 2
False Positive Result 2 2
Mechanical Problem 2 2
Kinked 2 2
Backflow 2 2
Partial Blockage 2 2
Positioning Failure 2 2
Crack 2 2
Shelf Life Exceeded 2 2
Device Inoperable 2 2
Volume Accuracy Problem 2 2
Component Missing 2 2
Off-Label Use 2 2
Material Puncture/Hole 1 1
Reflux within Device 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Failure to Sense 1 1
Material Separation 1 1
Device Emits Odor 1 1
Material Opacification 1 1
Particulates 1 1
Device Difficult to Setup or Prepare 1 1
Increase in Pressure 1 1
Failure to Prime 1 1
Device Contamination with Body Fluid 1 1
Failure to Deliver 1 1
Material Perforation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 566 566
Reaction 104 104
No Clinical Signs, Symptoms or Conditions 93 93
No Information 86 86
Low Blood Pressure/ Hypotension 63 85
Death 61 61
No Code Available 52 52
Hypervolemia 51 51
No Consequences Or Impact To Patient 51 51
Hemolysis 45 45
Insufficient Information 40 40
No Patient Involvement 30 30
Blood Loss 29 29
Hypersensitivity/Allergic reaction 28 50
Itching Sensation 27 27
Dyspnea 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 43
Test Result 20 20
Nausea 20 20
Rash 18 18
Anemia 17 17
Tachycardia 16 16
Hemorrhage/Bleeding 16 16
Chest Pain 15 15
Vomiting 15 24
Cardiac Arrest 13 13
Air Embolism 12 12
Fever 12 12
Local Reaction 12 12
Electrolyte Imbalance 12 34
Urticaria 11 11
Loss of consciousness 8 8
Paresthesia 8 17
Thrombocytopenia 8 8
Sepsis 8 21
High Blood Pressure/ Hypertension 7 7
Unspecified Infection 7 29
Bradycardia 7 7
Bacterial Infection 7 7
Chest Tightness/Pressure 7 7
Hypovolemia 7 7
Dizziness 7 7
Hematoma 6 6
Pain 6 6
Erythema 5 5
Low Oxygen Saturation 5 5
Numbness 5 5
Complaint, Ill-Defined 5 5
Syncope/Fainting 5 5
Heart Failure/Congestive Heart Failure 5 5
Liver Failure 5 5
Cramp(s) /Muscle Spasm(s) 4 4
Anxiety 4 4
Discomfort 4 4
Swelling 4 4
Diarrhea 4 13
Pulmonary Embolism 4 4
Overdose 4 4
Seizures 4 4
Hypoxia 3 3
Respiratory Distress 3 3
Abdominal Pain 3 3
Viral Infection 3 3
Sweating 3 3
Cough 3 3
Swelling/ Edema 3 3
Sore Throat 3 3
Unspecified Respiratory Problem 2 2
Unspecified Heart Problem 2 2
Diaphoresis 2 2
Malaise 2 2
Pallor 2 2
Increased Respiratory Rate 2 2
Venipuncture 2 2
Chills 2 2
Cramp(s) 2 2
Angina 2 2
Arrhythmia 2 2
Bruise/Contusion 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Cardiopulmonary Arrest 2 2
Stroke/CVA 2 2
Headache 2 2
Edema 2 2
Paralysis 2 2
Thrombosis 2 2
Hypovolemic Shock 2 2
Inflammation 2 2
Muscle Spasm(s) 2 2
Muscular Rigidity 1 1
Ischemia 1 1
Hypothermia 1 1
Hyperthermia 1 1
Hyperventilation 1 1
Intracranial Hemorrhage 1 1
Hyperbilirubinemia 1 1
Thrombus 1 1
Therapeutic Effects, Unexpected 1 1
Shock 1 1
Skin Discoloration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Caridian BCT, Incorporated II Nov-16-2011
2 Caridian BCT, Incorporated II Jun-28-2011
3 CaridianBCT, Inc. II May-30-2012
4 CaridianBCT, Inc. II May-09-2012
5 Fenwal Inc II Mar-15-2023
6 Fenwal Inc II Apr-02-2021
7 Fenwal Inc II Jun-08-2013
8 Fresenius Kabi, LLC II May-16-2011
9 Fresenius Kabi, LLC I Dec-16-2010
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