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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sucker, cardiotomy return, cardiopulmonary bypass
Product CodeDTS
Regulation Number 870.4420
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 11 11
2022 11 11
2023 12 12
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 9 9
Material Deformation 9 9
Mechanical Problem 7 7
Obstruction of Flow 6 6
Detachment of Device or Device Component 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Material Separation 4 4
Crack 3 3
Material Puncture/Hole 3 3
Material Integrity Problem 3 3
Complete Blockage 2 2
Material Protrusion/Extrusion 2 2
Off-Label Use 1 1
Restricted Flow rate 1 1
Contamination 1 1
Component Missing 1 1
No Apparent Adverse Event 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 46
Unspecified Infection 3 3
Foreign Body In Patient 2 2
Insufficient Information 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Perforation 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Pseudoaneurysm 1 1
Hypovolemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Perfusion Systems II May-10-2024
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