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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device detector, bubble, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass bubble detector.
Product CodeKRL
Regulation Number 870.4205
Device Class 2

MDR Year MDR Reports MDR Events
2022 20 20
2023 17 17
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 21 21
Device Sensing Problem 14 14
Over-Sensing 6 6
Under-Sensing 3 3
Deflation Problem 2 2
False Alarm 2 2
Disconnection 1 1
Leak/Splash 1 1
Failure to Sense 1 1
Difficult to Open or Close 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
Air Embolism 1 1

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