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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 donor livers prior to transplantation
Definition The device is intended for machine preservation of donor livers prior to transplantation.
Product CodeQQK
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 0 2 4 10 4

MDR Year MDR Reports MDR Events
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 3 3
Power Problem 2 2
Insufficient Information 2 2
Physical Resistance/Sticking 1 1
Failure to Charge 1 1
Contamination 1 1
Failure to Read Input Signal 1 1
Low Readings 1 1
Charging Problem 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Liver Damage/Dysfunction 5 5
Thrombosis/Thrombus 2 2
Insufficient Information 2 2

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