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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suction control, intracardiac, cardiopulmonary bypass
Product CodeDWD
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

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