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	90	96
Adverse Event Without Identified Device or Use Problem	48	55
Noise, Audible	42	43
Device Difficult to Setup or Prepare	35	39
Unexpected Shutdown	34	37
Infusion or Flow Problem	27	33
Mechanical Problem	25	32
Electrical /Electronic Property Problem	20	20
Device Alarm System	18	18
No Apparent Adverse Event	17	19
Pumping Stopped	15	19
Display or Visual Feedback Problem	10	10
Overheating of Device	8	11
Fluid/Blood Leak	4	4
Product Quality Problem	4	6
Use of Device Problem	4	4
Failure to Interrogate	3	3
Power Problem	3	3
Excessive Heating	3	4
Communication or Transmission Problem	3	3
Increased Pump Speed	2	4
Failure to Power Up	2	2
No Audible Alarm	2	2
Decreased Pump Speed	2	2
Material Deformation	2	2
Electrical Power Problem	2	3
Failure of Device to Self-Test	2	2
Contamination /Decontamination Problem	1	1
Backflow	1	1
Vibration	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Calibration Problem	1	1
Pumping Problem	1	1
Fracture	1	1
Display Difficult to Read	1	1
Premature Separation	1	1
Malposition of Device	1	1
Improper or Incorrect Procedure or Method	1	1
No Flow	1	1
No Display/Image	1	2
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	257	277
Hemorrhage/Bleeding	13	15
Thrombosis/Thrombus	12	17
Multiple Organ Failure	10	11
Insufficient Information	8	9
Hemolysis	7	8
Heart Failure/Congestive Heart Failure	7	9
Low Blood Pressure/ Hypotension	5	5
Tachycardia	5	6
Renal Failure	5	7
Stroke/CVA	4	6
Ischemia Stroke	4	5
Bacterial Infection	4	4
Hypoxia	4	6
Brain Injury	3	5
Fungal Infection	3	3
Atrial Fibrillation	3	4
Cardiac Arrest	3	4
Ventricular Fibrillation	3	3
Sepsis	2	2
Respiratory Failure	2	3
Hemothorax	2	3
Thromboembolism	2	2
Purulent Discharge	2	2
Septic Shock	2	2
Renal Impairment	2	3
Visual Impairment	2	4
Endocarditis	2	2
Urinary Tract Infection	1	1
Hypervolemia	1	1
Pulmonary Embolism	1	1
Low Oxygen Saturation	1	1
Atrial Flutter	1	1
Aortic Valve Insufficiency/ Regurgitation	1	1
Respiratory Insufficiency	1	1
Convulsion/Seizure	1	1
Unspecified Respiratory Problem	1	1
Thrombocytopenia	1	1
Bradycardia	1	1
Pneumonia	1	1
Cardiogenic Shock	1	1
Cardiac Tamponade	1	1
Respiratory Acidosis	1	1
Hemorrhagic Stroke	1	1
Anemia	1	2
Coagulation Disorder	1	1
Muscle Weakness	1	1
Abdominal Distention	1	2
Hematoma	1	2
Hematuria	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Perfusion Systems	II	Nov-14-2025