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TPLC - Total Product Life Cycle
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TPLC
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Device
catheter, hemodialysis, implanted, coated
Definition
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Product Code
NYU
Regulation Number
876.5540
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
6
6
2020
4
4
2021
1
1
2022
16
16
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
11
11
Material Puncture/Hole
6
6
Leak/Splash
5
5
Insufficient Flow or Under Infusion
3
3
Migration
3
3
Product Quality Problem
2
2
Defective Component
2
2
Detachment of Device or Device Component
1
1
Material Integrity Problem
1
1
Pumping Problem
1
1
Insufficient Information
1
1
Device Difficult to Setup or Prepare
1
1
Material Frayed
1
1
Difficult to Remove
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
16
16
No Consequences Or Impact To Patient
9
9
Insufficient Information
8
8
Unintended Radiation Exposure
3
3
No Information
2
2
Numbness
1
1
Air Embolism
1
1
Bacterial Infection
1
1
Dyspnea
1
1
Endocarditis
1
1
Hemorrhage/Bleeding
1
1
Pain
1
1
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