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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, photopheresis, extracorporeal
Product CodeLNR
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
4 1 7 5 7 2 5 5 8 4 2 1 2 3 3 0

MDR Year MDR Reports MDR Events
2014 377 377
2015 319 319
2016 318 318
2017 261 261
2018 183 183
2019 161 161
2020 141 141
2021 114 114
2022 97 97
2023 83 83
2024 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 908 908
Leak/Splash 659 659
Device Displays Incorrect Message 564 564
Break 408 408
Adverse Event Without Identified Device or Use Problem 155 155
Device Alarm System 90 90
Noise, Audible 82 82
Device Contamination with Body Fluid 55 55
Air Leak 55 55
Device Operates Differently Than Expected 52 52
Crack 41 41
Detachment Of Device Component 41 41
Occlusion Within Device 28 28
Hole In Material 26 26
Insufficient Information 23 23
Improper or Incorrect Procedure or Method 21 21
Coagulation in Device or Device Ingredient 21 21
Device Dislodged or Dislocated 18 18
Detachment of Device or Device Component 18 18
Disconnection 17 17
Pressure Problem 17 17
Protective Measures Problem 16 16
Use of Device Problem 15 15
Material Puncture/Hole 12 12
Loose or Intermittent Connection 11 11
Torn Material 11 11
Gas/Air Leak 11 11
Unintended Ejection 10 10
Material Fragmentation 10 10
Defective Alarm 9 9
Output Problem 9 9
Obstruction of Flow 9 9
Visual Prompts will not Clear 8 8
Display or Visual Feedback Problem 8 8
Burst Container or Vessel 8 8
Material Separation 7 7
Failure to Prime 7 7
Infusion or Flow Problem 7 7
Bent 7 7
Device Emits Odor 6 6
Split 6 6
Loss of Power 6 6
Positioning Problem 5 5
Component Falling 5 5
Vibration 4 4
Defective Component 4 4
Sticking 4 4
Kinked 4 4
Moisture or Humidity Problem 4 4
Material Twisted/Bent 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 866 866
No Clinical Signs, Symptoms or Conditions 382 382
Blood Loss 211 211
No Consequences Or Impact To Patient 204 204
Hemorrhage/Bleeding 120 120
No Information 53 53
No Code Available 53 53
Low Blood Pressure/ Hypotension 52 52
Dyspnea 39 39
Pulmonary Embolism 33 33
Thrombosis 27 27
Death 20 21
Nausea 20 20
Anemia 19 19
Tachycardia 17 17
Malaise 17 17
Low Oxygen Saturation 15 15
Chest Pain 14 14
Unspecified Infection 14 14
Thrombus 14 14
No Patient Involvement 12 12
Dizziness 12 12
Patient Problem/Medical Problem 11 11
Insufficient Information 11 11
Swelling 10 10
High Blood Pressure/ Hypertension 10 10
Fever 10 10
Vomiting 9 9
Pain 9 9
Hypoxia 9 9
Fainting 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Fatigue 8 8
Pallor 7 7
Headache 7 7
Test Result 7 7
Tingling 7 7
Numbness 6 6
Complaint, Ill-Defined 6 6
Chills 5 5
Weakness 5 5
Respiratory Failure 5 5
Paresthesia 5 5
Hyperglycemia 5 5
Multiple Organ Failure 5 5
Reaction 5 5
Itching Sensation 5 5
Respiratory Distress 5 5
Abdominal Pain 5 5
Hemolysis 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Mallinckrodt Pharmaceuticals Ireland Ltd II Feb-07-2022
2 Therakos Inc II Apr-05-2016
3 Therakos Inc II Jul-19-2011
4 Therakos Inc II Apr-28-2011
5 Therakos Inc II May-26-2010
6 Therakos, Inc. II Nov-05-2021
7 Therakos, Inc. II Jan-11-2012
8 Therakos, Inc. II Aug-10-2011
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