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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoadsorption column for emergency use
Definition Extracorporeal carbon dioxide removal from blood for use during declared public health emergency.
Product CodeQLO
Device Class Not Classified

MDR Year MDR Reports MDR Events
2025 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 13 13
Lack of Effect 9 9
Complete Blockage 2 2
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5
Cancer 5 5
Low Blood Pressure/ Hypotension 4 4
Coagulation Disorder 3 3
Hemorrhage/Bleeding 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Gastrointestinal Hemorrhage 2 2
Pallor 2 2
Pleural Effusion 2 2
Loss of consciousness 2 2
Arrhythmia 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Ischemia 1 1
Anemia 1 1
Chest Pain 1 1
Pain 1 1
Bradycardia 1 1
Asystole 1 1
Thrombocytopenia 1 1

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