Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
tubing, pump, cardiopulmonary bypass
Product Code
DWE
Regulation Number
870.4390
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
134
134
2019
82
82
2020
45
45
2021
41
41
2022
124
124
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
96
96
Disconnection
37
37
Leak/Splash
33
33
Device Operates Differently Than Expected
22
22
Defective Component
20
20
Obstruction of Flow
20
20
Noise, Audible
20
20
Crack
17
17
Break
13
13
Adverse Event Without Identified Device or Use Problem
12
12
Material Deformation
11
11
Pressure Problem
11
11
Misassembled
10
10
Material Separation
10
10
Increase in Pressure
9
9
Misassembled During Installation
9
9
Insufficient Flow or Under Infusion
8
8
Mechanical Problem
8
8
Material Puncture/Hole
7
7
Improper Flow or Infusion
7
7
Air/Gas in Device
6
6
Packaging Problem
6
6
Pumping Problem
5
5
No Flow
5
5
Infusion or Flow Problem
5
5
Component Missing
5
5
Material Fragmentation
5
5
Loose or Intermittent Connection
4
4
Restricted Flow rate
4
4
Material Discolored
4
4
Coagulation in Device or Device Ingredient
4
4
Detachment Of Device Component
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Failure to Prime
4
4
Defective Device
3
3
Device Displays Incorrect Message
3
3
Detachment of Device or Device Component
3
3
Improper or Incorrect Procedure or Method
3
3
Gas/Air Leak
3
3
Output Problem
3
3
Patient Device Interaction Problem
3
3
Component Misassembled
3
3
Therapeutic or Diagnostic Output Failure
2
2
Insufficient Information
2
2
Appropriate Term/Code Not Available
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Chemical Problem
2
2
Connection Problem
2
2
Device Dislodged or Dislocated
2
2
Pumping Stopped
2
2
Complete Blockage
2
2
Air Leak
2
2
Particulates
2
2
Fracture
2
2
Inaccurate Flow Rate
1
1
Incorrect Measurement
1
1
Gas Output Problem
1
1
Loss of Power
1
1
Decrease in Pressure
1
1
Moisture Damage
1
1
Nonstandard Device
1
1
Delivered as Unsterile Product
1
1
No Device Output
1
1
Backflow
1
1
Partial Blockage
1
1
Circuit Failure
1
1
Clumping in Device or Device Ingredient
1
1
Collapse
1
1
Contamination
1
1
Decoupling
1
1
No Display/Image
1
1
Display or Visual Feedback Problem
1
1
Entrapment of Device
1
1
Unintended Ejection
1
1
Material Perforation
1
1
Device Damaged Prior to Use
1
1
Malposition of Device
1
1
Deformation Due to Compressive Stress
1
1
Product Quality Problem
1
1
Difficult to Remove
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Failure to Sense
1
1
Failure to Read Input Signal
1
1
Sticking
1
1
Tidal Volume Fluctuations
1
1
Filtration Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Free or Unrestricted Flow
1
1
Device Packaging Compromised
1
1
Device Sensing Problem
1
1
Device Markings/Labelling Problem
1
1
Torn Material
1
1
No Apparent Adverse Event
1
1
Separation Problem
1
1
Material Integrity Problem
1
1
Mechanical Jam
1
1
Medical Gas Supply Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
135
135
No Known Impact Or Consequence To Patient
100
100
No Consequences Or Impact To Patient
68
68
No Patient Involvement
49
49
Hemorrhage/Bleeding
34
34
Death
21
21
Low Oxygen Saturation
9
9
Blood Loss
7
7
Hypovolemia
6
6
Hemolysis
4
4
Hypoxia
4
4
Insufficient Information
4
4
Ischemia
3
3
No Information
3
3
No Code Available
3
3
Thrombosis
2
2
Injury
2
2
Unspecified Infection
2
2
Stroke/CVA
2
2
Exsanguination
2
2
Bradycardia
2
2
Cardiac Arrest
1
1
Adhesion(s)
1
1
Air Embolism
1
1
Fistula
1
1
Inflammation
1
1
Low Blood Pressure/ Hypotension
1
1
Hypothermia
1
1
Internal Organ Perforation
1
1
Pain
1
1
Pneumonia
1
1
Abdominal Distention
1
1
Pericardial Effusion
1
1
Thrombosis/Thrombus
1
1
Unspecified Tissue Injury
1
1
Complaint, Ill-Defined
1
1
Hernia
1
1
Respiratory Acidosis
1
1
Respiratory Failure
1
1
Cardiac Perforation
1
1
Vascular System (Circulation), Impaired
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Datascope Corporation
II
Oct-11-2018
2
Datascope Corporation
III
Jun-06-2018
3
Datascope Corporation
II
May-08-2018
4
LivaNova USA
III
Feb-21-2018
5
LivaNova USA Inc.
III
Feb-27-2020
-
-