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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2020
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2024
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Device
circulator, breathing-circuit
Product Code
CAG
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
2024
2
2
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
Gas/Air Leak
11
11
Hole In Material
11
11
Misassembled
9
9
Infusion or Flow Problem
7
7
Connection Problem
5
5
Fitting Problem
5
5
Device Inoperable
4
4
Material Puncture/Hole
4
4
Occlusion Within Device
3
3
Loss of or Failure to Bond
3
3
Detachment Of Device Component
3
3
Defective Component
3
3
Failure to Deliver
3
3
Detachment of Device or Device Component
3
3
Cut In Material
2
2
Device Damaged Prior to Use
2
2
Disassembly
2
2
Thermal Decomposition of Device
2
2
Mechanical Problem
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
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
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
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
37
37
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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