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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
Definition An extracorporeal system for carbon dioxide removal is a system of devices and accessories that provides assisted extracorporeal carbon dioxide removal from the patient's blood in patients with acute respiratory failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, a gas exchanger, blood pump, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).
Product CodeQOH
Regulation Number 870.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
ALUNG TECHNOLOGIES, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2023 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 27 27
Insufficient Information 20 20
Device Handling Problem 2 2
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 10 10
Anemia 9 9
Thrombocytopenia 7 7
No Clinical Signs, Symptoms or Conditions 3 3
Low Blood Pressure/ Hypotension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hemolysis 2 2
Cardiac Arrest 2 2
Epistaxis 2 2
Melena 1 1
Arrhythmia 1 1
Stroke/CVA 1 1
Respiratory Arrest 1 1
Abnormal Blood Gases 1 1
Hematuria 1 1
Embolism/Embolus 1 1
Pleural Effusion 1 1
Septic Shock 1 1
Cardiogenic Shock 1 1
Hypothermia 1 1
Pneumonia 1 1
Hemothorax 1 1
Respiratory Failure 1 1

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