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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 132 132
2024 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 564 608
Insufficient Information 319 319
Inadequate User Interface 162 162
Device Displays Incorrect Message 133 133
Data Problem 126 126
Improper or Incorrect Procedure or Method 112 112
Patient Data Problem 103 103
Use of Device Problem 92 92
Excess Flow or Over-Infusion 50 50
No Apparent Adverse Event 48 48
Nonstandard Device 48 48
Fluid/Blood Leak 48 48
Patient-Device Incompatibility 47 47
Device Operates Differently Than Expected 40 40
Incorrect Software Programming Calculations 38 38
Air Leak 26 26
Leak/Splash 18 18
Device Operational Issue 17 17
Programming Issue 16 16
Occlusion Within Device 15 15
Device Alarm System 13 13
Insufficient Flow or Under Infusion 13 13
Gas/Air Leak 12 12
Obstruction of Flow 12 12
Improper Flow or Infusion 11 11
Infusion or Flow Problem 11 11
Break 10 10
Appropriate Term/Code Not Available 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
Human-Device Interface Problem 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Output Problem 6 6
Defective Component 6 6
Defective Device 6 6
Therapeutic or Diagnostic Output Failure 6 6
Device Handling Problem 5 5
Material Discolored 5 5
Use of Incorrect Control/Treatment Settings 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Component Falling 5 5
Noise, Audible 5 5
Disconnection 5 5
Microbial Contamination of Device 4 4
Device Disinfection Or Sterilization Issue 4 4
Clumping in Device or Device Ingredient 4 4
Display or Visual Feedback Problem 4 4
Incorrect Or Inadequate Test Results 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 566 566
No Clinical Signs, Symptoms or Conditions 118 118
Reaction 104 104
No Information 86 86
Low Blood Pressure/ Hypotension 80 102
Death 61 61
Hypervolemia 53 53
No Code Available 52 52
No Consequences Or Impact To Patient 51 51
Hemolysis 48 48
Insufficient Information 41 41
Hypersensitivity/Allergic reaction 34 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 54
No Patient Involvement 30 30
Blood Loss 29 29
Itching Sensation 28 28
Dyspnea 24 24
Rash 20 20
Nausea 20 20
Test Result 20 20
Tachycardia 19 19
Vomiting 17 26
Anemia 17 17
Hemorrhage/Bleeding 17 17
Fever 15 15
Chest Pain 15 15
Local Reaction 14 14
Cardiac Arrest 13 13
Urticaria 13 13
Electrolyte Imbalance 12 34
Air Embolism 12 12
Paresthesia 10 19
Sepsis 9 22
Dizziness 9 9
Syncope/Fainting 9 9
Bradycardia 8 8
Thrombocytopenia 8 8
Bacterial Infection 8 8
Loss of consciousness 8 8
High Blood Pressure/ Hypertension 8 8
Hematoma 7 7
Chest Tightness/Pressure 7 7
Unspecified Infection 7 29
Hypovolemia 7 7
Pain 6 6
Swelling/ Edema 5 5
Heart Failure/Congestive Heart Failure 5 5
Complaint, Ill-Defined 5 5
Numbness 5 5
Low Oxygen Saturation 5 5

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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