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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device circulator, breathing-circuit
Regulation Description Breathing circuit circulator.
Product CodeCAG
Regulation Number 868.5250
Device Class 2

Device Problems
Leak 32
Melted 24
Crack 15
Disconnection 11
Split 11
Misassembled 9
Hole in material 8
Infusion or flow issue 7
Connection issue 5
Device inoperable 4
Fitting problem 3
Loss of or failure to bond 3
Detachment of device component 3
Failure to deliver 3
Cut in material 2
Detachment of device or device component 2
Dislodged or dislocated 2
Temperature issue 2
Burn of device or device component 2
Disassembly 2
Occlusion within device 2
Material separation 1
Device damaged prior to use 1
Suction issue 1
Break 1
Torn material 1
Foreign material present in device 1
Material integrity issue 1
Delivery system failure 1
Total Device Problems 160

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