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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 4

MDR Year MDR Reports MDR Events
2024 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 14 14
Power Problem 7 7
Low Readings 6 6
Infusion or Flow Problem 5 5
Fluid/Blood Leak 4 4
Failure to Pump 4 4
Pumping Stopped 3 3
Complete Blockage 3 3
High Readings 3 3
Physical Resistance/Sticking 3 3
Loose or Intermittent Connection 2 2
Battery Problem 2 2
Contamination 2 2
Premature Discharge of Battery 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Read Input Signal 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Charge 1 1
Charging Problem 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
Liver Damage/Dysfunction 14 14
Low Blood Pressure/ Hypotension 12 12
Thrombosis/Thrombus 2 2
Insufficient Information 2 2

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