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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
2014
107
107
2016
1
1
2017
2
2
2018
3
3
2019
3
3
2020
2
2
2021
11
11
2022
11
11
2023
12
12
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Over-Sensing
34
34
Device Dislodged or Dislocated
21
21
High Capture Threshold
14
14
Low impedance
11
11
Disconnection
11
11
Failure to Capture
9
9
High impedance
9
9
Mechanical Problem
7
7
Detachment of Device or Device Component
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Material Deformation
6
6
Device Sensing Problem
5
5
Failure to Sense
5
5
Material Separation
4
4
Device Operates Differently Than Expected
4
4
Detachment Of Device Component
4
4
Break
4
4
Sensing Intermittently
3
3
Material Puncture/Hole
3
3
Difficult to Remove
3
3
Material Integrity Problem
3
3
Decreased Sensitivity
3
3
Under-Sensing
2
2
Failure to Advance
2
2
Material Protrusion/Extrusion
2
2
Difficult to Advance
2
2
Retraction Problem
2
2
Crack
2
2
Capturing Problem
2
2
No Apparent Adverse Event
1
1
Intermittent Capture
1
1
Entrapment of Device
1
1
Restricted Flow rate
1
1
Fluid/Blood Leak
1
1
Loose or Intermittent Connection
1
1
Particulates
1
1
Off-Label Use
1
1
Device Contamination with Chemical or Other Material
1
1
Low Sensing Threshold
1
1
Device Slipped
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
92
92
No Clinical Signs, Symptoms or Conditions
33
33
No Consequences Or Impact To Patient
8
8
Foreign Body In Patient
3
3
Insufficient Information
2
2
Death
2
2
Hemorrhage/Bleeding
2
2
Undesired Nerve Stimulation
2
2
Dizziness
2
2
Pseudoaneurysm
2
2
Exit Block
2
2
No Patient Involvement
1
1
Muscle Stimulation
1
1
Device Embedded In Tissue or Plaque
1
1
Mitral Valve Insufficiency/ Regurgitation
1
1
Unspecified Tissue Injury
1
1
Perforation
1
1
Perforation of Vessels
1
1
Hypovolemia
1
1
Discomfort
1
1
Atrial Perforation
1
1
Cardiac Perforation
1
1
Claudication
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
California Medical Laboratories Inc
II
Jan-07-2013
2
International Biophysics Corp
II
Nov-23-2011
3
International Biophysics Corp.
II
Aug-19-2015
4
Terumo Cardiovascular Systems Corporation
II
Oct-17-2011
5
Terumo Cardiovascular Systems Corporation
II
Aug-04-2009
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