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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
2014 72 72
2015 31 31
2016 4 4
2017 38 38
2018 6 6
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
Air Leak 109 109
Loss of or Failure to Bond 93 93
Leak/Splash 44 44
Gas/Air Leak 23 23
Pressure Problem 20 20
Decrease in Pressure 15 15
Device Contamination with Chemical or Other Material 12 12
Crack 9 9
Unintended Deflation 6 6
Inflation Problem 6 6
Disconnection 5 5
Break 5 5
Appropriate Term/Code Not Available 5 5
Mechanical Problem 4 4
Fluid/Blood Leak 4 4
Material Integrity Problem 4 4
Device Operates Differently Than Expected 4 4
Missing Value Reason 4 4
Detachment of Device or Device Component 4 4
Burst Container or Vessel 3 3
Device Markings/Labelling Problem 3 3
Insufficient Information 3 3
Defective Device 3 3
Material Split, Cut or Torn 2 2
Detachment Of Device Component 2 2
Deflation Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Backflow 2 2
Inaccurate Delivery 2 2
Fracture 2 2
Infusion or Flow Problem 2 2
Device Handling Problem 2 2
Inadequate User Interface 1 1
Component Falling 1 1
Device Issue 1 1
Failure to Deflate 1 1
Explosion 1 1
Free or Unrestricted Flow 1 1
Misassembly by Users 1 1
Material Rupture 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Flow or Under Infusion 1 1
Improper Flow or Infusion 1 1
Obstruction of Flow 1 1
Component Missing 1 1
Use of Device Problem 1 1
Material Fragmentation 1 1
Air/Gas in Device 1 1
Contamination 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 109 109
No Clinical Signs, Symptoms or Conditions 86 86
Insufficient Information 26 26
No Consequences Or Impact To Patient 25 25
No Code Available 6 6
No Information 6 6
Missing Value Reason 6 6
Air Embolism 5 5
No Patient Involvement 3 3
Low Blood Pressure/ Hypotension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Death 2 2
Cardiac Arrest 2 2
Urinary Tract Infection 2 2
Hearing Impairment 1 1
Arrhythmia 1 1
Not Applicable 1 1
Respiratory Arrest 1 1
Misdiagnosis 1 1
Embolism/Embolus 1 1
Atrial Fibrillation 1 1
Foreign Body In Patient 1 1
Sudden Cardiac Death 1 1
Respiratory Insufficiency 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jun-26-2017
2 GE Healthcare, LLC II Jun-24-2011
3 Merit Medical Systems, Inc. II Dec-14-2009
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