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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
Regulation Description Cardiopulmonary bypass intracardiac suction control.
Product CodeDWD
Regulation Number 870.4430
Device Class 2

Device Problems
No Apparent Adverse Event 10
Leak / Splash 2
Pressure Problem 1
Detachment Of Device Component 1
Hole In Material 1
Restricted Flow rate 1
Detachment of Device or device Component 1
Loss of or Failure to Bond 1
Suction Problem 1
Delivered as Unsterile Product 1
Connection Problem 1
Valve 1
Contamination During Use 1
Total Device Problems 23


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