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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Definition To preserve donor lungs prior to transplantation
Product CodeQBA
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 1 5 2 2 1

MDR Year MDR Reports MDR Events
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Structural Problem 1 1
Infusion or Flow Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Protective Measures Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Discomfort 1 1

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