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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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2024
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Device
infusor, pressure, for i.v. bags
Product Code
KZD
Regulation Number
880.5420
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
4
4
2020
8
8
2021
13
13
2022
45
45
2023
31
31
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
28
28
Pressure Problem
15
15
Gas/Air Leak
14
14
Unintended Deflation
6
6
Material Integrity Problem
4
4
Mechanical Problem
4
4
Decrease in Pressure
4
4
Disconnection
4
4
Break
3
3
Burst Container or Vessel
3
3
Crack
3
3
Defective Device
3
3
Detachment of Device or Device Component
2
2
Inflation Problem
2
2
Device Handling Problem
2
2
Fluid/Blood Leak
2
2
Fracture
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Use of Device Problem
1
1
Failure to Zero
1
1
Insufficient Flow or Under Infusion
1
1
Component Missing
1
1
Inaccurate Delivery
1
1
Obstruction of Flow
1
1
Material Fragmentation
1
1
No Display/Image
1
1
Deflation Problem
1
1
Contamination
1
1
Explosion
1
1
Material Split, Cut or Torn
1
1
Failure to Deflate
1
1
Air/Gas in Device
1
1
Backflow
1
1
Free or Unrestricted Flow
1
1
Inadequate User Interface
1
1
Infusion or Flow Problem
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
63
63
Insufficient Information
24
24
Air Embolism
3
3
No Known Impact Or Consequence To Patient
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Urinary Tract Infection
2
2
No Patient Involvement
1
1
Foreign Body In Patient
1
1
Not Applicable
1
1
Embolism/Embolus
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Arrhythmia
1
1
Atrial Fibrillation
1
1
Cardiac Arrest
1
1
Hearing Impairment
1
1
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