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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)
2021 2022 2023 2024 2025 2026
2 3 3 0 3 0

MDR Year MDR Reports MDR Events
2021 114 114
2022 97 97
2023 83 83
2024 151 151
2025 148 148
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 437 437
Break 68 68
Leak/Splash 63 63
Coagulation in Device or Device Ingredient 43 43
Adverse Event Without Identified Device or Use Problem 26 26
Protective Measures Problem 13 13
Output Problem 7 7
Crack 7 7
Use of Device Problem 7 7
Display or Visual Feedback Problem 6 6
Detachment of Device or Device Component 5 5
Obstruction of Flow 4 4
Priming Problem 3 3
Disconnection 2 2
Pressure Problem 2 2
Material Puncture/Hole 2 2
Insufficient Information 2 2
Problem with Software Installation 2 2
Air/Gas in Device 2 2
Unintended Ejection 2 2
Gas/Air Leak 2 2
Material Twisted/Bent 2 2
Noise, Audible 2 2
Activation, Positioning or Separation Problem 1 1
Burst Container or Vessel 1 1
Device Alarm System 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Infusion or Flow Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Rupture 1 1
Misassembly by Users 1 1
Material Separation 1 1
Installation-Related Problem 1 1
Connection Problem 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 568 568
Low Blood Pressure/ Hypotension 13 13
Dyspnea 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Paresthesia 8 8
Tachycardia 7 7
Low Oxygen Saturation 7 7
Anemia 5 5
Insufficient Information 5 5
Pulmonary Embolism 4 4
Chest Pain 4 4
Nausea 4 4
Air Embolism 3 3
High Blood Pressure/ Hypertension 3 3
Blurred Vision 3 3
Malaise 3 3
Numbness 2 2
Hematuria 2 2
Sepsis 2 2
Fatigue 2 2
Headache 2 2
Hemolysis 2 2
Hemorrhage/Bleeding 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Myocardial Infarction 1 1
Cyanosis 1 1
Abdominal Pain 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Stroke/CVA 1 1
Septic Shock 1 1
Shock 1 1
Pain 1 1
Paralysis 1 1
Pneumonia 1 1
Pulmonary Edema 1 1
Visual Impairment 1 1
Vomiting 1 1
Burning Sensation 1 1
Chills 1 1
Dizziness 1 1
Respiratory Failure 1 1
Shaking/Tremors 1 1
Confusion/ Disorientation 1 1
Multiple Organ Failure 1 1
Convulsion/Seizure 1 1
Syncope/Fainting 1 1
Movement Disorder 1 1

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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