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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

Device Problems
False Alarm 8
Device Operational Issue 5
Pumping Stopped 3
Device Displays Incorrect Message 2
Material Integrity Problem 2
Device Alarm System 2
Unexpected Shutdown 2
Physical Property Issue 1
Device Issue 1
Communication or Transmission Problem 1
Incorrect, Inadequate or Imprecise Result or Readings 1
Failure to Sense 1
Bubble Detector 1
Sensing Intermittently 1
Alarm 1
Appropriate Term/Code Not Available 1
Fracture 1
Total Device Problems 34


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