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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
Regulation Description Cardiopulmonary bypass cardiotomy return sucker.
Product CodeDTS
Regulation Number 870.4420
Device Class 2

Device Problems
Over-Sensing 34
Device Dislodged or Dislocated 21
High Capture Threshold 14
Low impedance 11
Failure to Capture 9
High impedance 8
Adverse Event Without Identified Device or Use Problem 6
Device Sensing Problem 5
Failure to Sense 5
Break 3
Device Operates Differently Than Expected 3
Decreased Sensitivity 3
Sensing Intermittently 3
Insulation 3
Difficult to Remove 3
Detachment Of Device Component 2
Under-Sensing 2
Retraction Problem 2
Failure to Advance 2
Difficult to Advance 2
Capturing Problem 2
Device Contamination with Chemical or Other Material 1
Helifix Coil 1
Mechanical Problem 1
Low Sensing Threshold 1
Intermittent Capture 1
Entrapment of Device 1
Device Slipped 1
Particulates 1
Total Device Problems 151

Recalls
Manufacturer Recall Class Date Posted
1 International Biophysics Corp. II Aug-19-2015

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