TPLC - Total Product Life Cycle

show TPLC since

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 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 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
Cardiac Arrest	2	2
Hemolysis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Epistaxis	2	2
Respiratory Arrest	1	1
Melena	1	1
Embolism/Embolus	1	1
Abnormal Blood Gases	1	1
Hemothorax	1	1
Stroke/CVA	1	1
Arrhythmia	1	1
Hypothermia	1	1
Pleural Effusion	1	1
Pneumonia	1	1
Septic Shock	1	1
Cardiogenic Shock	1	1
Respiratory Failure	1	1
Hematuria	1	1