TPLC - Total Product Life Cycle

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Device	blood pump for ecmo, long-term (> 6 hours) use
Regulation Description	Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Definition	A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Product Code	QNR
Regulation Number	870.4100
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT (FORMERLY THORATEC CORPORATION)
	SUBSTANTIALLY EQUIVALENT	1
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CARDIACASSIST, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICHIGAN CRITICAL CARE CONSULTANTS, INC. (D.B.A MC3 INC.)
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	96	102
Adverse Event Without Identified Device or Use Problem	54	61
Noise, Audible	44	45
Unexpected Shutdown	37	40
Device Difficult to Setup or Prepare	37	41
Infusion or Flow Problem	30	36
Mechanical Problem	28	35
No Apparent Adverse Event	22	24
Electrical /Electronic Property Problem	21	21
Device Alarm System	19	19
Pumping Stopped	15	19
Display or Visual Feedback Problem	13	13
Overheating of Device	7	10
Fluid/Blood Leak	5	5
Use of Device Problem	4	4
Product Quality Problem	4	6
Excessive Heating	4	5
Failure to Interrogate	3	3
Communication or Transmission Problem	3	3
Power Problem	3	3
Decreased Pump Speed	2	2
No Audible Alarm	2	2
Increased Pump Speed	2	4
Failure to Power Up	2	2
Gas/Air Leak	2	2
Electrical Power Problem	2	3
Material Deformation	2	2
Fracture	2	2
Failure of Device to Self-Test	2	2
Vibration	1	1
Contamination /Decontamination Problem	1	1
Backflow	1	1
Pumping Problem	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Display Difficult to Read	1	1
Calibration Problem	1	1
Premature Separation	1	1
Malposition of Device	1	1
No Display/Image	1	2
Improper or Incorrect Procedure or Method	1	1
No Flow	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	274	294
Hemorrhage/Bleeding	13	15
Thrombosis/Thrombus	13	18
Multiple Organ Failure	11	12
Insufficient Information	8	9
Hemolysis	7	8
Heart Failure/Congestive Heart Failure	7	9
Tachycardia	5	6
Renal Failure	5	7
Ischemia Stroke	4	5
Low Blood Pressure/ Hypotension	4	4
Bacterial Infection	4	4
Stroke/CVA	4	6
Hypoxia	4	6
Ventricular Fibrillation	3	3
Cardiac Arrest	3	4
Atrial Fibrillation	3	4
Fungal Infection	3	3
Brain Injury	3	5
Air Embolism	3	3
Purulent Discharge	2	2
Septic Shock	2	2
Visual Impairment	2	4
Renal Impairment	2	3
Endocarditis	2	2
Sepsis	2	2
Thromboembolism	2	2
Hemothorax	2	3
Respiratory Failure	2	3
Abdominal Distention	1	2
Anemia	1	2
Muscle Weakness	1	1
Ischemia	1	1
Hemorrhagic Stroke	1	1
Hematoma	1	2
Cardiac Tamponade	1	1
Respiratory Acidosis	1	1
Exsanguination	1	1
Coagulation Disorder	1	1
Cardiogenic Shock	1	1
Hematuria	1	1
Bradycardia	1	1
Pneumonia	1	1
Low White Blood Cell Count	1	1
Convulsion/Seizure	1	1
Thrombocytopenia	1	1
Unspecified Respiratory Problem	1	1
Arrhythmia	1	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Aortic Valve Insufficiency/ Regurgitation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Perfusion Systems	II	Nov-14-2025
2	Thoratec LLC	II	Jan-15-2026