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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
2023 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 26 26
Pressure Problem 18 18
Gas/Air Leak 9 9
Unintended Deflation 6 6
Mechanical Problem 4 4
Decrease in Pressure 4 4
Break 3 3
Disconnection 3 3
Defective Device 3 3
Material Integrity Problem 3 3
Infusion or Flow Problem 2 2
Device Handling Problem 2 2
Detachment of Device or Device Component 2 2
Fluid/Blood Leak 2 2
Fracture 2 2
Inflation Problem 2 2
Burst Container or Vessel 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
Device Issue 1 1
Obstruction of Flow 1 1
Contamination 1 1
Deflation Problem 1 1
No Display/Image 1 1
Air Leak 1 1
Backflow 1 1
Inadequate User Interface 1 1
Device Operational Issue 1 1
Free or Unrestricted Flow 1 1
Material Split, Cut or Torn 1 1
Failure to Deflate 1 1
Misassembly by Users 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Air/Gas in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
Insufficient Information 17 17
No Known Impact Or Consequence To Patient 6 6
Air Embolism 4 4
Cardiac Arrest 2 2
Urinary Tract Infection 2 2
No Code Available 2 2
Missing Value Reason 2 2
Embolism/Embolus 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
Not Applicable 1 1
Death 1 1
Hearing Impairment 1 1
Arrhythmia 1 1
Atrial Fibrillation 1 1

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