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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
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
28
28
Gas/Air Leak
23
23
Pressure Problem
16
16
Unintended Deflation
6
6
Disconnection
5
5
Decrease in Pressure
5
5
Crack
4
4
Material Integrity Problem
4
4
Mechanical Problem
4
4
Break
4
4
Detachment of Device or Device Component
4
4
Device Markings/Labelling Problem
3
3
Defective Device
3
3
Fluid/Blood Leak
3
3
Burst Container or Vessel
3
3
Material Split, Cut or Torn
2
2
Insufficient Information
2
2
Fracture
2
2
Inaccurate Delivery
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Inflation Problem
2
2
Device Handling Problem
2
2
Failure to Zero
1
1
Appropriate Term/Code Not Available
1
1
Inadequate User Interface
1
1
Deflation Problem
1
1
Air/Gas in Device
1
1
Contamination
1
1
Material Fragmentation
1
1
Use of Device Problem
1
1
Obstruction of Flow
1
1
Component Missing
1
1
Backflow
1
1
Incomplete or Inadequate Connection
1
1
No Display/Image
1
1
Insufficient Flow or Under Infusion
1
1
Infusion or Flow Problem
1
1
Explosion
1
1
Free or Unrestricted Flow
1
1
Failure to Deflate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
86
86
Insufficient Information
26
26
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
Hearing Impairment
1
1
Arrhythmia
1
1
Not Applicable
1
1
Respiratory Arrest
1
1
Embolism/Embolus
1
1
Atrial Fibrillation
1
1
Cardiac Arrest
1
1
Foreign Body In Patient
1
1
No Patient Involvement
1
1
Respiratory Insufficiency
1
1
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