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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extracorporeal system for carbon dioxide removal for the treatment of covid-19
Definition to treat lung failure due to COVID-19 when used as an adjunct to noninvasive or invasive mechanical ventilation in reducing hypercapnia and hypercapnic acidosis due to Coronavirus Disease 2019 (COVID-19), and/or maintaining normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved.
Product CodeQLN
Device Class Not Classified

MDR Year MDR Reports MDR Events
2023 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 33 33
Defective Component 4 4
Connection Problem 1 1
Insufficient Information 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 13 13
Anemia 11 11
No Clinical Signs, Symptoms or Conditions 8 8
Renal Failure 3 3
Cardiac Arrest 2 2
Pneumothorax 2 2
Hematoma 1 1
Ischemia 1 1
Septic Shock 1 1
Melena 1 1
Liver Failure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alung Technologies Inc II Jan-29-2021
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