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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
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 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 8 8
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 8 8
Material Puncture/Hole 4 4
Obstruction of Flow 1 1
Material Deformation 1 1
Air/Gas in Device 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11

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