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Device
tubing, pump, cardiopulmonary bypass
Regulation Description
Cardiopulmonary bypass pump tubing.
Product Code
DWE
Regulation Number
870.4390
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
81
81
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
421
421
Material Separation
71
71
Obstruction of Flow
67
67
Air/Gas in Device
58
58
Material Puncture/Hole
53
53
Crack
49
49
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
Detachment of Device or Device Component
5
5
Packaging Problem
5
5
Material Twisted/Bent
4
4
Component Misassembled
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
666
666
Hemorrhage/Bleeding
121
121
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
Anemia
1
1
Pericardial Effusion
1
1
Cardiac Arrest
1
1
Paralysis
1
1
Cardiac Perforation
1
1
Thrombosis/Thrombus
1
1
Thrombosis
1
1
Congenital Defect/Deformity
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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