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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
2018 3 3
2019 3 3
2020 2 2
2021 11 11
2022 11 11
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 11 11
Material Deformation 6 6
Detachment of Device or Device Component 5 5
Material Separation 4 4
Material Integrity Problem 3 3
Mechanical Problem 3 3
Material Puncture/Hole 3 3
Material Protrusion/Extrusion 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 1 1
Device Slipped 1 1
Component Missing 1 1
Crack 1 1
Particulates 1 1
Entrapment of Device 1 1
Restricted Flow rate 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
No Consequences Or Impact To Patient 3 3
Hemorrhage/Bleeding 2 2
Pseudoaneurysm 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Unspecified Tissue Injury 1 1
Perforation 1 1
Perforation of Vessels 1 1
Hypovolemia 1 1

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