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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device single lumen ecmo cannula
Regulation Description Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Definition Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use 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 CodeQHW
Regulation Number 870.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2022 1 1
2023 8 9
2024 18 21
2025 7 7
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 17 18
Mechanical Problem 8 8
Material Deformation 8 9
Material Puncture/Hole 7 8
Obstruction of Flow 5 7
Fluid/Blood Leak 3 3
Break 1 1
Air/Gas in Device 1 1
Adverse Event Without Identified Device or Use Problem 1 2
Unexpected Color 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 38
Hemorrhage/Blood Loss/Bleeding 3 4
Arrhythmia 1 1
Stroke/CVA 1 2
Sepsis 1 2
Ischemia 1 1
Foreign Body In Patient 1 1
Renal Failure 1 2
Convulsion/Seizure 1 2
Low Blood Pressure/ Hypotension 1 1

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