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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oxygenator, long term support greater than 6 hours
Product CodeBYS
Regulation Number 870.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
MC3 INC.
  SUBSTANTIALLY EQUIVALENT 1
MC3 INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 5 5
2022 2 2
2023 20 20
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 22 22
Infusion or Flow Problem 16 16
Mechanical Problem 8 8
Air/Gas in Device 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Obstruction of Flow 2 2
No Apparent Adverse Event 2 2
Increase in Pressure 2 2
Leak/Splash 1 1
Crack 1 1
Insufficient Information 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Use of Device Problem 1 1
Partial Blockage 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47
Ischemia 7 7
Embolism/Embolus 7 7
Thrombosis/Thrombus 7 7
Insufficient Information 4 4
Hemorrhage/Bleeding 2 2
Air Embolism 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hemolysis 1 1
Unspecified Blood or Lymphatic problem 1 1
Alteration in Body Temperature 1 1
Respiratory Insufficiency 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mc3 Inc II Mar-19-2024
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