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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device sucker, cardiotomy return, cardiopulmonary bypass
Product CodeDTS
Regulation Number 870.4420
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2018 3 3
2019 3 3
2020 2 2
2021 11 11
2022 11 11

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 5 5
Pseudoaneurysm 2 2
No Patient Involvement 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypovolemia 1 1
Atrial Perforation 1 1
Hemorrhage/Bleeding 1 1
Perforation 1 1
Perforation of Vessels 1 1

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