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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
Regulation Description Pressure infusor for an I.V. bag.
Product CodeKZD
Regulation Number 880.5420
Device Class 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 13 13
2022 45 45
2023 31 31
2024 43 43
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 34 34
Gas/Air Leak 31 31
Material Split, Cut or Torn 17 17
Pressure Problem 16 16
Material Integrity Problem 14 14
Inflation Problem 11 11
Disconnection 8 8
Unintended Deflation 7 7
Decrease in Pressure 6 6
Mechanical Problem 5 5
Device Markings/Labelling Problem 5 5
Fluid/Blood Leak 5 5
Break 4 4
Crack 4 4
Defective Device 4 4
Detachment of Device or Device Component 4 4
Failure to Zero 3 3
Fracture 3 3
Infusion or Flow Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Burst Container or Vessel 2 2
Incomplete or Inadequate Connection 2 2
Insufficient Information 2 2
Connection Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Material Fragmentation 2 2
Inaccurate Delivery 2 2
Device Handling Problem 2 2
Product Quality Problem 2 2
Inadequate User Interface 1 1
Failure to Deflate 1 1
Appropriate Term/Code Not Available 1 1
Failure to Infuse 1 1
Explosion 1 1
Device Sensing Problem 1 1
Material Separation 1 1
Material Rupture 1 1
Insufficient Flow or Under Infusion 1 1
Obstruction of Flow 1 1
Use of Device Problem 1 1
Backflow 1 1
Air/Gas in Device 1 1
Deflation Problem 1 1
Contamination 1 1
Filling Problem 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 140 140
Insufficient Information 28 28
Air Embolism 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
Respiratory Insufficiency 1 1

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