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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 7

MDR Year MDR Reports MDR Events
2024 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 15 15
Power Problem 7 7
Low Readings 6 6
Failure to Pump 6 6
Infusion or Flow Problem 6 6
Premature Discharge of Battery 5 5
Physical Resistance/Sticking 5 5
Fluid/Blood Leak 4 4
Complete Blockage 3 3
Failure to Charge 3 3
Pumping Stopped 3 3
High Readings 3 3
Battery Problem 3 3
No Apparent Adverse Event 2 2
Restricted Flow rate 2 2
Pumping Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Contamination 2 2
Charging Problem 2 2
Loose or Intermittent Connection 2 2
Defective Component 1 1
Incorrect Measurement 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Read Input Signal 1 1
Filtration Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Communication or Transmission Problem 1 1
Failure to Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57 57
Liver Damage/Dysfunction 17 17
Low Blood Pressure/ Hypotension 12 12
Insufficient Information 4 4
Thrombosis/Thrombus 2 2
Cardiac Arrest 1 1

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