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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 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 511 555
Insufficient Information 230 230
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 91 91
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 28 28
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
Obstruction of Flow 12 12
Gas/Air Leak 12 12
Infusion or Flow Problem 11 11
Improper Flow or Infusion 11 11
Break 10 10
Appropriate Term/Code Not Available 10 10
Misassembled 10 10
High Test Results 8 8
Coagulation in Device or Device Ingredient 8 8
Contamination of Device Ingredient or Reagent 7 7
Device Misassembled During Manufacturing /Shipping 6 6
Output Problem 6 6
Defective Device 6 6
Therapeutic or Diagnostic Output Failure 6 6
Defective Component 6 6
Material Discolored 5 5
Human-Device Interface Problem 5 5
Noise, Audible 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Component Falling 5 5
Disconnection 5 5
Use of Incorrect Control/Treatment Settings 5 5
Pressure Problem 4 4
Detachment Of Device Component 4 4
Device Disinfection Or Sterilization Issue 4 4
Microbial Contamination of Device 4 4
Incorrect Or Inadequate Test Results 4 4
Display or Visual Feedback Problem 4 4
Clumping in Device or Device Ingredient 4 4
Contamination 3 3
Unexpected Therapeutic Results 3 3
Expiration Date Error 3 3
False Reading From Device Non-Compliance 3 3
Contamination /Decontamination Problem 3 3
Torn Material 3 3
Device Slipped 3 3
Device Contamination with Chemical or Other Material 3 3
Complete Blockage 3 3
Device Handling Problem 3 3
Positioning Failure 2 2
Off-Label Use 2 2
Pumping Problem 2 2
Misassembly by Users 2 2
Partial Blockage 2 2
Air/Gas in Device 2 2
Material Deformation 2 2
Detachment of Device or Device Component 2 2
Mechanical Problem 2 2
Shelf Life Exceeded 2 2
Inaccurate Delivery 2 2
Crack 2 2
Volume Accuracy Problem 2 2
Loose or Intermittent Connection 2 2
Kinked 2 2
Backflow 2 2
Component Misassembled 2 2
Difficult to Open or Close 2 2
No Flow 2 2
Component Missing 2 2
Material Twisted/Bent 2 2
False Positive Result 2 2
Inaccurate Flow Rate 2 2
Device Inoperable 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Contamination with Body Fluid 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Improper Device Output 1 1
Device Sensing Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Optical Discoloration 1 1
Failure to Sense 1 1
Visual Prompts will not Clear 1 1
Material Disintegration 1 1
Failure to Prime 1 1
No Audible Alarm 1 1
Particulates 1 1
Failure to Deliver 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 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 Information 86 86
No Clinical Signs, Symptoms or Conditions 81 81
Death 61 61
Low Blood Pressure/ Hypotension 58 80
No Code Available 52 52
No Consequences Or Impact To Patient 51 51
Hypervolemia 49 49
Hemolysis 42 42
Insufficient Information 39 39
No Patient Involvement 30 30
Blood Loss 29 29
Hypersensitivity/Allergic reaction 28 50
Itching Sensation 26 26
Dyspnea 22 22
Test Result 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 41
Rash 18 18
Nausea 17 17
Tachycardia 15 15
Hemorrhage/Bleeding 15 15
Chest Pain 13 13
Cardiac Arrest 13 13
Vomiting 12 21
Air Embolism 12 12
Electrolyte Imbalance 12 34
Anemia 11 11
Fever 11 11
Local Reaction 11 11
Loss of consciousness 8 8
Sepsis 8 21
Paresthesia 8 17
Urticaria 8 8
Chest Tightness/Pressure 7 7
Bradycardia 7 7
Bacterial Infection 7 7
High Blood Pressure/ Hypertension 7 7
Unspecified Infection 7 29
Dizziness 7 7
Hypovolemia 6 6
Low Oxygen Saturation 5 5
Hematoma 5 5
Liver Failure 5 5
Syncope/Fainting 5 5
Pain 5 5
Erythema 5 5
Thrombocytopenia 5 5
Complaint, Ill-Defined 5 5
Heart Failure/Congestive Heart Failure 5 5
Cramp(s) /Muscle Spasm(s) 4 4
Anxiety 4 4
Seizures 4 4
Pulmonary Embolism 4 4
Swelling 4 4
Numbness 4 4
Diarrhea 4 13
Discomfort 4 4
Overdose 4 4
Swelling/ Edema 3 3
Hypoxia 3 3
Viral Infection 3 3
Sweating 3 3
Sore Throat 3 3
Respiratory Distress 3 3
Cough 3 3
Unspecified Respiratory Problem 2 2
Hypovolemic Shock 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Angina 2 2
Thrombosis 2 2
Muscle Spasm(s) 2 2
Inflammation 2 2
Malaise 2 2
Pallor 2 2
Cramp(s) 2 2
Chills 2 2
Abdominal Pain 2 2
Arrhythmia 2 2
Stroke/CVA 2 2
Cardiopulmonary Arrest 2 2
Venipuncture 2 2
Paralysis 2 2
Headache 2 2
Unspecified Heart Problem 2 2
Diaphoresis 2 2
Increased Respiratory Rate 2 2
Bruise/Contusion 2 2
Edema 2 2
Apnea 1 1
Pulmonary Edema 1 1
Hyperbilirubinemia 1 1
Tingling 1 1
Patient Problem/Medical Problem 1 1
Electric Shock 1 1
Respiratory Failure 1 1
Hyperthermia 1 1
Fall 1 1
Collapse 1 1
Renal Failure 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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