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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
2019 13 13
2020 2 2
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 10 10
Leak/Splash 5 5
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Device Slipped 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 14 14
No Clinical Signs, Symptoms or Conditions 2 2
Blood Loss 1 1

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