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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
suction control, intracardiac, cardiopulmonary bypass
Product Code
DWD
Regulation Number
870.4430
Device Class
2
MDR Year
MDR Reports
MDR Events
2016
6
6
2017
12
12
2018
8
8
2019
13
13
2020
2
2
2022
1
1
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
19
19
Fluid/Blood Leak
15
15
No Apparent Adverse Event
10
10
Pressure Problem
2
2
Suction Problem
2
2
Microbial Contamination of Device
1
1
Detachment of Device or Device Component
1
1
Device Operates Differently Than Expected
1
1
Difficult to Open or Close
1
1
Infusion or Flow Problem
1
1
Mechanical Problem
1
1
Delivered as Unsterile Product
1
1
Device Slipped
1
1
Sticking
1
1
Loss of or Failure to Bond
1
1
Detachment Of Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
30
30
Blood Loss
6
6
No Known Impact Or Consequence To Patient
4
4
No Clinical Signs, Symptoms or Conditions
2
2
No Information
1
1
Patient Problem/Medical Problem
1
1
-
-