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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 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
Infusion or Flow Problem 6 6
Failure to Pump 6 6
Low Readings 6 6
Physical Resistance/Sticking 5 5
Premature Discharge of Battery 5 5
Fluid/Blood Leak 4 4
Failure to Charge 3 3
Complete Blockage 3 3
Pumping Stopped 3 3
High Readings 3 3
Battery Problem 3 3
Restricted Flow rate 2 2
Pumping Problem 2 2
Contamination 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Charging Problem 2 2
No Apparent Adverse Event 2 2
Loose or Intermittent Connection 2 2
Failure to Read Input Signal 1 1
Communication or Transmission Problem 1 1
Filtration Problem 1 1
Defective Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect Measurement 1 1
Tear, Rip or Hole in Device Packaging 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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