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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubing, pump, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass pump tubing.
Product CodeDWE
Regulation Number 870.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
LIVANOVA USA INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 45 45
2021 41 41
2022 123 123
2023 287 287
2024 222 222
2025 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 420 420
Obstruction of Flow 67 67
Material Separation 66 66
Air/Gas in Device 58 58
Material Puncture/Hole 53 53
Crack 46 46
Disconnection 44 44
Material Deformation 38 38
Misassembled During Installation 31 31
Leak/Splash 17 17
Misassembled 14 14
Tear, Rip or Hole in Device Packaging 13 13
Noise, Audible 11 11
Mechanical Problem 11 11
Component Missing 10 10
Break 8 8
Material Split, Cut or Torn 7 7
Increase in Pressure 6 6
No Flow 5 5
Fracture 5 5
Component Misassembled 5 5
Detachment of Device or Device Component 5 5
Packaging Problem 5 5
Material Twisted/Bent 4 4
No Apparent Adverse Event 4 4
Defective Component 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Loose or Intermittent Connection 3 3
Contamination 3 3
Difficult to Remove 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Gas/Air Leak 3 3
Infusion or Flow Problem 3 3
Decoupling 3 3
Chemical Problem 2 2
Mechanical Jam 2 2
Connection Problem 2 2
Coagulation in Device or Device Ingredient 2 2
Device Dislodged or Dislocated 2 2
Delivered as Unsterile Product 2 2
Insufficient Flow or Under Infusion 2 2
Improper Flow or Infusion 2 2
Output Problem 2 2
Pressure Problem 1 1
Separation Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Compatibility Problem 1 1
Device Slipped 1 1
Inaccurate Flow Rate 1 1
Device Difficult to Setup or Prepare 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 662 662
Hemorrhage/Bleeding 119 119
No Consequences Or Impact To Patient 29 29
Insufficient Information 10 10
Air Embolism 7 7
No Known Impact Or Consequence To Patient 6 6
No Patient Involvement 6 6
Hypovolemia 6 6
Blood Loss 4 4
Death 3 3
Low Oxygen Saturation 3 3
Ischemia 2 2
Bradycardia 2 2
Hypoxia 2 2
Low Blood Pressure/ Hypotension 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hemolysis 1 1
Embolism/Embolus 1 1
Pericardial Effusion 1 1
Anemia 1 1
Thrombosis/Thrombus 1 1
Cardiac Perforation 1 1
Paralysis 1 1
Thrombosis 1 1
Heart Failure/Congestive Heart Failure 1 1
Internal Organ Perforation 1 1
Ischemia Stroke 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LivaNova USA Inc. III Feb-27-2020
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