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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dual lumen ecmo cannula
Regulation Description Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Definition Long term support greater than 6 hours for acute respiratory 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 CodePZS
Regulation Number 870.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDIACASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
MC3, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 12 14
2022 28 28
2023 10 10
2024 11 11
2025 35 35
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 28 30
Adverse Event Without Identified Device or Use Problem 21 21
Mechanical Problem 17 17
Air/Gas in Device 13 13
Obstruction of Flow 12 12
Crack 11 11
Material Puncture/Hole 7 7
Use of Device Problem 7 7
Material Deformation 6 6
Material Integrity Problem 4 4
Fluid/Blood Leak 4 4
Unintended Movement 3 3
Break 3 3
Migration 2 2
Positioning Problem 2 2
Material Frayed 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Malposition of Device 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 49
Hemorrhage/Blood Loss/Bleeding 21 21
Pericardial Effusion 11 11
Perforation 10 10
Air Embolism 10 10
Perforation of Vessels 6 6
Unspecified Infection 5 5
Insufficient Information 5 5
Cardiac Tamponade 5 5
Brain Injury 4 4
Respiratory Insufficiency 4 4
Thrombosis/Thrombus 4 4
Cardiac Arrest 4 4
Shock 4 4
Embolism/Embolus 4 4
Low Blood Pressure/ Hypotension 3 3
Cerebral Edema 2 2
Reperfusion Injury 2 2
Bradycardia 2 2
Hypoxia 2 2
Septic Shock 2 2
Low Oxygen Saturation 2 2
Multiple Organ Dysfunction Syndrome 2 2
Viral Infection 2 2
No Known Impact Or Consequence To Patient 1 1
Reduced Blood Flow 1 1
Tissue Damage 1 1
Intimal Dissection 1 1
Exposure to Body Fluids 1 1
Valvular Insufficiency/ Regurgitation 1 1
Convulsion/Seizure 1 1
Swelling/ Edema 1 1
Cardiac Perforation 1 1
Respiratory Failure 1 1
Arrhythmia 1 1
Hematoma 1 1
Diminished Pulse Pressure 1 1
Stroke/CVA 1 1
Death 1 1
Foreign Body In Patient 1 1

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