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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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Device
flowmeter, tube, thorpe, back-pressure compensated
Product Code
CAX
Regulation Number
868.2340
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
2
2
2017
4
4
2018
3
3
2019
6
6
2020
1
1
2021
6
6
2022
1
1
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Peeled/Delaminated
4
4
Crack
4
4
Burst Container or Vessel
3
3
Therapeutic or Diagnostic Output Failure
2
2
Defective Component
2
2
Gas Output Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Misassembly by Users
2
2
Unsealed Device Packaging
1
1
Inadequate Instructions for Healthcare Professional
1
1
Material Fragmentation
1
1
Air Leak
1
1
Device Operates Differently Than Expected
1
1
Appropriate Term/Code Not Available
1
1
Material Rupture
1
1
Use of Incorrect Control/Treatment Settings
1
1
Material Separation
1
1
Detachment of Device or Device Component
1
1
Free or Unrestricted Flow
1
1
Device Inoperable
1
1
Inadequate User Interface
1
1
Detachment Of Device Component
1
1
Break
1
1
Use of Device Problem
1
1
Material Twisted/Bent
1
1
Excess Flow or Over-Infusion
1
1
Infusion or Flow Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
8
8
No Clinical Signs, Symptoms or Conditions
6
6
Death
5
5
Low Oxygen Saturation
5
5
No Consequences Or Impact To Patient
2
2
No Information
1
1
Insufficient Information
1
1
Cardiopulmonary Arrest
1
1
Bradycardia
1
1
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