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TPLC
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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
MDR Year
MDR Reports
MDR Events
2016
151
151
2017
131
131
2018
134
134
2019
83
83
2020
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
73
73
Leak/Splash
60
60
Fluid Leak
59
59
Crack
22
22
Noise, Audible
21
21
Disconnection
20
20
Defective Component
19
19
Break
17
17
Device Displays Incorrect Message
16
16
Pressure Problem
16
16
Adverse Event Without Identified Device or Use Problem
14
14
Improper Flow or Infusion
14
14
No Flow
13
13
Increase in Pressure
13
13
Air Leak
11
11
Tube
11
11
Failure to Prime
11
11
Insufficient Flow or Under Infusion
10
10
Detachment Of Device Component
10
10
Port
9
9
Loose or Intermittent Connection
9
9
Occlusion Within Device
9
9
Infusion or Flow Problem
9
9
Insufficient Information
9
9
Misassembled
8
8
Improper or Incorrect Procedure or Method
8
8
Kinked
7
7
Restricted Flow rate
7
7
Material Discolored
6
6
Connection Problem
6
6
Gas Leak
6
6
Complete Blockage
6
6
Incorrect, Inadequate or Imprecise Resultor Readings
5
5
Material Fragmentation
5
5
Cap
5
5
Pumping Problem
5
5
Defective Device
5
5
Obstruction of Flow
5
5
Device Inoperable
5
5
Connector
5
5
Coagulation in Device or Device Ingredient
4
4
Sensor
4
4
Device Damaged Prior to Use
4
4
Device Misassembled During Manufacturing /Shipping
4
4
Device Contamination with Chemical or Other Material
4
4
Device Dislodged or Dislocated
4
4
No Display/Image
4
4
Pumping Stopped
4
4
Hole In Material
4
4
Incorrect Measurement
3
3
Nonstandard Device
3
3
Display or Visual Feedback Problem
3
3
Luer Valve
3
3
Cable, Electrical
3
3
Filter
3
3
Probe
3
3
Output Problem
3
3
Torn Material
3
3
Patient Device Interaction Problem
3
3
Improper Device Output
3
3
Decrease in Pressure
3
3
Fiber
3
3
Partial Blockage
3
3
Jaw
2
2
Contamination
2
2
Lock
2
2
Valve(s)
2
2
Inaccurate Flow Rate
2
2
Moisture Damage
2
2
Unable to Obtain Readings
2
2
Malposition of Device
2
2
Device Contamination with Body Fluid
2
2
Material Deformation
2
2
Material Integrity Problem
2
2
Incorrect Device Or Component Shipped
2
2
Temperature Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Filtration Problem
2
2
Stopcock
2
2
Incorrect Or Inadequate Test Results
2
2
Communication or Transmission Problem
2
2
Detachment of Device or Device Component
2
2
Device Packaging Compromised
2
2
Device Slipped
2
2
Difficult to Remove
2
2
Gas Output Problem
2
2
Particulates
2
2
Loss of Power
1
1
Failure to Sense
1
1
Material Separation
1
1
No Device Output
1
1
Collapse
1
1
Fracture
1
1
Reservoir
1
1
Display
1
1
Manifold
1
1
False Device Output
1
1
False Reading From Device Non-Compliance
1
1
Unintended Ejection
1
1
No Audible Alarm
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
256
256
No Consequences Or Impact To Patient
100
100
No Patient Involvement
70
70
Death
37
37
No Information
22
22
Low Oxygen Saturation
14
14
Blood Loss
9
9
Hemolysis
8
8
Hemorrhage/Bleeding
6
6
No Code Available
5
5
Air Embolism
4
4
Ischemia
3
3
Thrombus
3
3
Injury
3
3
Bradycardia
3
3
Cardiac Arrest
3
3
Unspecified Infection
3
3
Stroke/CVA
2
2
Hypoxia
2
2
Brain Injury
2
2
Pulmonary Embolism
2
2
Thrombosis
2
2
Exsanguination
2
2
Low Blood Pressure/ Hypotension
1
1
Hypothermia
1
1
Renal Failure
1
1
Sepsis
1
1
Respiratory Acidosis
1
1
Respiratory Failure
1
1
Sudden Cardiac Death
1
1
Hypovolemia
1
1
Toxicity
1
1
Coma
1
1
Transient Ischemic Attack
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Complaint, Ill-Defined
1
1
Vascular System (Circulation), Impaired
1
1
Patient Problem/Medical Problem
1
1
Myocardial Infarction
1
1
Pneumonia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics Inc. (Navilyst Medical Inc.)
II
May-20-2016
2
Datascope Corporation
II
Oct-11-2018
3
Datascope Corporation
III
Jun-06-2018
4
Datascope Corporation
II
May-08-2018
5
Datascope Corporation
II
Mar-23-2017
6
Datascope Corporation
II
Jun-15-2016
7
LivaNova USA
III
Feb-21-2018
8
LivaNova USA Inc.
III
Feb-27-2020
9
Maquet
II
Dec-20-2017
10
Sorin Group USA, Inc.
II
Jul-29-2017
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