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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)
2019 2020 2021 2022 2023 2024
2 1 2 3 3 0

MDR Year MDR Reports MDR Events
2019 161 161
2020 141 141
2021 114 114
2022 97 97
2023 83 83
2024 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 397 397
Leak/Splash 157 157
Break 140 140
Adverse Event Without Identified Device or Use Problem 61 61
Coagulation in Device or Device Ingredient 24 24
Device Displays Incorrect Message 21 21
Protective Measures Problem 16 16
Crack 12 12
Use of Device Problem 11 11
Gas/Air Leak 9 9
Detachment of Device or Device Component 9 9
Output Problem 9 9
Display or Visual Feedback Problem 7 7
Material Puncture/Hole 6 6
Device Alarm System 6 6
Obstruction of Flow 5 5
Improper or Incorrect Procedure or Method 4 4
Noise, Audible 4 4
Air/Gas in Device 4 4
Disconnection 3 3
Unintended Ejection 3 3
Material Twisted/Bent 2 2
Insufficient Information 2 2
Explosion 2 2
Material Split, Cut or Torn 2 2
Pressure Problem 2 2
Problem with Software Installation 2 2
Device Fell 1 1
Priming Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Malposition of Device 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Material Frayed 1 1
Material Rupture 1 1
Material Separation 1 1
Unexpected Therapeutic Results 1 1
Use of Incorrect Control/Treatment Settings 1 1
Defective Alarm 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 394 394
No Known Impact Or Consequence To Patient 188 188
Dyspnea 23 23
Pulmonary Embolism 21 21
Blood Loss 16 16
Low Blood Pressure/ Hypotension 15 15
No Code Available 14 14
Tachycardia 12 12
Low Oxygen Saturation 11 11
Insufficient Information 11 11
No Consequences Or Impact To Patient 10 10
Chest Pain 10 10
Thrombosis 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Anemia 8 8
Nausea 6 6
Hemorrhage/Bleeding 5 5
Hypoxia 5 5
Malaise 5 5
Paresthesia 5 5
Thrombus 4 4
Pain 4 4
Dizziness 4 4
Numbness 4 4
Weakness 4 4
Tingling 3 3
Fatigue 3 3
Discomfort 3 3
Pallor 3 3
Ambulation Difficulties 2 2
Fainting 2 2
Blurred Vision 2 2
Cough 2 2
Anxiety 2 2
Pulmonary Edema 2 2
Bradycardia 2 2
No Patient Involvement 2 2
Swelling 2 2
Neck Pain 2 2
Abdominal Pain 2 2
Air Embolism 2 2
Chest Tightness/Pressure 2 2
Itching Sensation 2 2
Syncope/Fainting 2 2
Stroke/CVA 2 2
No Information 2 2
Hematuria 2 2
Wheezing 2 2
Sweating 2 2
Hemolysis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Mallinckrodt Pharmaceuticals Ireland Ltd II Feb-07-2022
2 Therakos, Inc. II Nov-05-2021
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