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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device infusor, pressure, for i.v. bags
Product CodeKZD
Regulation Number 880.5420
Device Class 1

MDR Year MDR Reports MDR Events
2018 6 6
2019 4 4
2020 8 8
2021 13 13
2022 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 24 24
Pressure Problem 17 17
Gas/Air Leak 4 4
Unintended Deflation 4 4
Decrease in Pressure 4 4
Defective Device 3 3
Mechanical Problem 3 3
Disconnection 3 3
Break 2 2
Burst Container or Vessel 2 2
Detachment of Device or Device Component 2 2
Device Handling Problem 2 2
Infusion or Flow Problem 2 2
Material Integrity Problem 2 2
Inflation Problem 2 2
Misassembly by Users 1 1
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Air/Gas in Device 1 1
Device Operational Issue 1 1
Free or Unrestricted Flow 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Insufficient Flow or Under Infusion 1 1
Component Missing 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Air Leak 1 1
Backflow 1 1
No Display/Image 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
Insufficient Information 8 8
No Known Impact Or Consequence To Patient 6 6
Urinary Tract Infection 2 2
No Code Available 2 2
Missing Value Reason 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Patient Involvement 1 1
Not Applicable 1 1
Air Embolism 1 1
Arrhythmia 1 1
Cardiac Arrest 1 1
Death 1 1
Hearing Impairment 1 1

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