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TPLC
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show TPLC since
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Device
suction control, intracardiac, cardiopulmonary bypass
Product Code
DWD
Regulation Number
870.4430
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
37
37
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
43
43
Fluid/Blood Leak
24
24
No Apparent Adverse Event
10
10
Device Operates Differently Than Expected
8
8
Device Contamination with Body Fluid
6
6
Pressure Problem
3
3
Suction Problem
3
3
Delivered as Unsterile Product
2
2
Device Slipped
2
2
Hole In Material
2
2
Mechanical Problem
1
1
Air Leak
1
1
Loss of or Failure to Bond
1
1
Detachment Of Device Component
1
1
Contamination
1
1
Restricted Flow rate
1
1
Sticking
1
1
Improper or Incorrect Procedure or Method
1
1
Failure to Prime
1
1
Structural Problem
1
1
Device Displays Incorrect Message
1
1
Connection Problem
1
1
Detachment of Device or Device Component
1
1
Microbial Contamination of Device
1
1
Difficult to Open or Close
1
1
Infusion or Flow Problem
1
1
Output below Specifications
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
37
37
No Known Impact Or Consequence To Patient
28
28
Blood Loss
12
12
No Information
4
4
Hemorrhage/Bleeding
3
3
No Clinical Signs, Symptoms or Conditions
2
2
Patient Problem/Medical Problem
1
1
Complaint, Ill-Defined
1
1
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