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	104	110
Adverse Event Without Identified Device or Use Problem	57	64
Noise, Audible	45	46
Device Difficult to Setup or Prepare	42	46
Unexpected Shutdown	37	40
Mechanical Problem	35	42
Infusion or Flow Problem	33	39
No Apparent Adverse Event	26	28
Electrical /Electronic Property Problem	23	23
Device Alarm System	20	20
Pumping Stopped	15	19
Display or Visual Feedback Problem	13	13
Overheating of Device	9	12
Use of Device Problem	6	6
Fluid/Blood Leak	6	6
Excessive Heating	5	6
Failure to Interrogate	4	4
Communication or Transmission Problem	4	4
Product Quality Problem	4	6
Vibration	3	3
Power Problem	3	3
Decreased Pump Speed	2	2
No Audible Alarm	2	2
Increased Pump Speed	2	4
Pumping Problem	2	2
Contamination /Decontamination Problem	2	2
Failure to Power Up	2	2
Electrical Power Problem	2	3
Obstruction of Flow	2	2
Gas/Air Leak	2	2
Material Deformation	2	2
Fracture	2	2
Failure of Device to Self-Test	2	2
No Display/Image	2	3
Manufacturing, Packaging or Shipping Problem	1	1
Backflow	1	1
Component Missing	1	1
Material Twisted/Bent	1	1
Display Difficult to Read	1	1
Calibration Problem	1	1
Malposition of Device	1	1
Unintended System Motion	1	1
Premature Separation	1	1
Disconnection	1	1
Improper or Incorrect Procedure or Method	1	1
No Flow	1	1
Circuit Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	300	320
Thrombosis/Thrombus	19	24
Hemorrhage/Bleeding	16	18
Insufficient Information	11	12
Multiple Organ Failure	10	11
Hemolysis	7	8
Heart Failure/Congestive Heart Failure	7	9
Ischemia Stroke	5	6
Tachycardia	5	6
Renal Failure	5	7
Air Embolism	4	4
Low Blood Pressure/ Hypotension	4	4
Stroke/CVA	4	6
Bacterial Infection	4	4
Hypoxia	4	6
Ventricular Fibrillation	3	3
Cardiac Arrest	3	4
Atrial Fibrillation	3	4
Coagulation Disorder	3	3
Fungal Infection	3	3
Brain Injury	3	5
Purulent Discharge	2	2
Ischemia	2	2
Exsanguination	2	2
Septic Shock	2	2
Visual Impairment	2	4
Renal Impairment	2	3
Endocarditis	2	2
Convulsion/Seizure	2	2
Sepsis	2	2
Thromboembolism	2	2
Hemothorax	2	3
Respiratory Failure	2	3
Anemia	1	2
Abdominal Distention	1	2
Muscle Weakness	1	1
Hemorrhagic Stroke	1	1
Cardiac Tamponade	1	1
Respiratory Acidosis	1	1
Hematoma	1	2
Cardiogenic Shock	1	1
Bradycardia	1	1
Pneumonia	1	1
Hematuria	1	1
Low White Blood Cell Count	1	1
Thrombocytopenia	1	1
Unspecified Respiratory Problem	1	1
Arrhythmia	1	2
Aortic Valve Insufficiency/ Regurgitation	1	1
Respiratory Insufficiency	1	1

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