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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
Product CodeCAG
Regulation Number 868.5250
Device Class 2

MDR Year MDR Reports MDR Events
2014 95 95
2015 41 41
2016 2 2
2017 2 2
2018 2 2
2019 3 3
2020 4 4
2021 13 13
2022 9 9
2023 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 39 39
Melted 28 28
Break 18 18
Crack 15 15
Material Separation 13 13
Split 11 11
Disconnection 11 11
Hole In Material 11 11
Gas/Air Leak 9 9
Misassembled 9 9
Infusion or Flow Problem 7 7
Connection Problem 5 5
Fitting Problem 5 5
Device Inoperable 4 4
Defective Component 3 3
Failure to Deliver 3 3
Detachment of Device or Device Component 3 3
Occlusion Within Device 3 3
Loss of or Failure to Bond 3 3
Detachment Of Device Component 3 3
Disassembly 2 2
Thermal Decomposition of Device 2 2
Material Puncture/Hole 2 2
Mechanical Problem 2 2
Cut In Material 2 2
Device Damaged Prior to Use 2 2
Human-Device Interface Problem 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Temperature Problem 2 2
Torn Material 1 1
Key or Button Unresponsive/not Working 1 1
Material Integrity Problem 1 1
No Fail-Safe Mechanism 1 1
Output Problem 1 1
Suction Problem 1 1
Failure to Align 1 1
Device Operates Differently Than Expected 1 1
Delivery System Failure 1 1
Device Displays Incorrect Message 1 1
Ambient Noise Problem 1 1
Communication or Transmission Problem 1 1
Unintended Ejection 1 1
Material Fragmentation 1 1
Material Rupture 1 1
Circuit Failure 1 1
Device Alarm System 1 1
Alarm Not Visible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 71 71
No Patient Involvement 63 63
No Clinical Signs, Symptoms or Conditions 35 35
No Known Impact Or Consequence To Patient 19 19
Insufficient Information 8 8
Low Oxygen Saturation 3 3
No Information 2 2
No Code Available 2 2
Death 1 1
Anxiety 1 1

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