Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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
Pumping Stopped 3 3
High Readings 3 3
Failure to Charge 3 3
Complete Blockage 3 3
Battery Problem 3 3
Contamination 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
No Apparent Adverse Event 2 2
Loose or Intermittent Connection 2 2
Restricted Flow rate 2 2
Pumping Problem 2 2
Charging Problem 2 2
Incorrect Measurement 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Calibrate 1 1
Failure to Read Input Signal 1 1
Defective Component 1 1
Communication or Transmission Problem 1 1
Filtration Problem 1 1
Adverse Event Without Identified Device or Use Problem 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

-
-