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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blood pump for ecmo, long-term (> 6 hours) use
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 CodeQNR
Regulation Number 870.4100
Device Class 2


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

MDR Year MDR Reports MDR Events
2021 1 1
2023 2 2
2024 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 31 31
Adverse Event Without Identified Device or Use Problem 18 18
Mechanical Problem 11 11
Noise, Audible 10 10
Device Difficult to Setup or Prepare 8 8
Pumping Stopped 7 7
Infusion or Flow Problem 7 7
No Apparent Adverse Event 7 7
Overheating of Device 6 6
Unexpected Shutdown 4 4
Communication or Transmission Problem 2 2
Increased Pump Speed 2 2
Product Quality Problem 2 2
No Display/Image 1 1
Malposition of Device 1 1
Electrical Power Problem 1 1
Excessive Heating 1 1
No Flow 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 67 67
Thrombosis/Thrombus 7 7
Multiple Organ Failure 4 4
Hemorrhage/Bleeding 4 4
Brain Injury 3 3
Insufficient Information 3 3
Heart Failure/Congestive Heart Failure 3 3
Renal Failure 3 3
Hypoxia 3 3
Ischemia Stroke 3 3
Stroke/CVA 2 2
Hemolysis 2 2
Cardiac Arrest 2 2
Visual Impairment 2 2
Arrhythmia 1 1
Sepsis 1 1
Coagulation Disorder 1 1
Hematoma 1 1
Muscle Weakness 1 1
Abdominal Distention 1 1
Anemia 1 1
Atrial Fibrillation 1 1
Renal Impairment 1 1
Tachycardia 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Respiratory Insufficiency 1 1
Hemothorax 1 1
Respiratory Failure 1 1

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