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TPLC
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Device
suction control, intracardiac, cardiopulmonary bypass
Regulation Description
Cardiopulmonary bypass intracardiac suction control.
Product Code
DWD
Regulation Number
870.4430
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
12
12
2018
8
8
2019
13
13
2020
2
2
2022
1
1
2023
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
18
18
Fluid/Blood Leak
12
12
No Apparent Adverse Event
10
10
Material Deformation
1
1
Delivered as Unsterile Product
1
1
Detachment Of Device Component
1
1
Device Slipped
1
1
Sticking
1
1
Microbial Contamination of Device
1
1
Pressure Problem
1
1
Loss of or Failure to Bond
1
1
Suction Problem
1
1
Detachment of Device or Device Component
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
30
30
No Known Impact Or Consequence To Patient
3
3
No Clinical Signs, Symptoms or Conditions
2
2
Blood Loss
2
2
Hemorrhage/Bleeding
1
1
Patient Problem/Medical Problem
1
1
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