TPLC - Total Product Life Cycle

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Device	extracorporeal system for carbon dioxide removal
Regulation Description	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 Code	QOH
Regulation Number	870.4150
Device Class	2

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 Device Problem Information	20	20
Device Handling Problem	2	2
Defective Component	1	1

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