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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
2021 12 14
2022 28 28
2023 10 10
2024 11 11
2025 35 35
2026 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 27 29
Adverse Event Without Identified Device or Use Problem 20 20
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 2 2
Positioning Problem 2 2
Migration 2 2
Material Frayed 1 1
Malposition of Device 1 1
Patient Device Interaction Problem 1 1
Packaging Problem 1 1
Material Separation 1 1
Material Protrusion/Extrusion 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 50
Hemorrhage/Blood Loss/Bleeding 21 21
Pericardial Effusion 11 11
Perforation 10 10
Air Embolism 8 8
Perforation of Vessels 6 6
Unspecified Infection 5 5
Cardiac Tamponade 5 5
Insufficient Information 5 5
Brain Injury 4 4
Embolism/Embolus 4 4
Cardiac Arrest 4 4
Thrombosis/Thrombus 4 4
Shock 4 4
Respiratory Insufficiency 4 4
Low Blood Pressure/ Hypotension 3 3
Multiple Organ Dysfunction Syndrome 2 2
Cardiac Perforation 2 2
Septic Shock 2 2
Viral Infection 2 2
Bradycardia 2 2
Hypoxia 2 2
Reperfusion Injury 2 2
Low Oxygen Saturation 2 2
Cerebral Edema 2 2
Arrhythmia 1 1
Stroke/CVA 1 1
Hematoma 1 1
Diminished Pulse Pressure 1 1
Valvular Insufficiency/ Regurgitation 1 1
Foreign Body In Patient 1 1
Exposure to Body Fluids 1 1
Swelling/ Edema 1 1
Respiratory Failure 1 1
Reduced Blood Flow 1 1

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