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TPLC
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show TPLC since
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2024
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Device
sucker, cardiotomy return, cardiopulmonary bypass
Product Code
DTS
Regulation Number
870.4420
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
3
3
2020
2
2
2021
11
11
2022
11
11
2023
12
12
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Disconnection
11
11
Mechanical Problem
6
6
Material Deformation
6
6
Detachment of Device or Device Component
6
6
Adverse Event Without Identified Device or Use Problem
5
5
Material Separation
4
4
Material Puncture/Hole
3
3
Material Integrity Problem
3
3
Crack
2
2
Material Protrusion/Extrusion
2
2
Off-Label Use
1
1
Restricted Flow rate
1
1
Component Missing
1
1
Obstruction of Flow
1
1
Fluid/Blood Leak
1
1
Contamination
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
34
34
Unspecified Infection
3
3
Insufficient Information
2
2
Pseudoaneurysm
2
2
Hemorrhage/Bleeding
2
2
No Consequences Or Impact To Patient
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Perforation
1
1
Foreign Body In Patient
1
1
Mitral Valve Insufficiency/ Regurgitation
1
1
Perforation of Vessels
1
1
Unspecified Tissue Injury
1
1
Hypovolemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Perfusion Systems
II
May-10-2024
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