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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
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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