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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system/device, pharmacy compounding
Regulation Description Intravascular administration set.
Product CodeNEP
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2021 130 132
2022 77 77
2023 91 92
2024 46 46
2025 29 29
2026 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Break 72 72
Fluid/Blood Leak 65 65
Application Program Problem: Dose Calculation Error 39 39
Disconnection 29 29
Device Contamination with Chemical or Other Material 18 18
Contamination 13 13
Crack 10 10
Material Split, Cut or Torn 9 9
Air/Gas in Device 8 8
Precipitate in Device or Device Ingredient 7 7
Loose or Intermittent Connection 7 7
Difficult to Open or Close 7 7
Contamination of Device Ingredient or Reagent 7 7
Detachment of Device or Device Component 7 7
Component Missing 6 6
Device Emits Odor 6 6
Microbial Contamination of Device 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Leak/Splash 3 3
Improper or Incorrect Procedure or Method 3 3
Device Alarm System 3 3
Contamination /Decontamination Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Expiration Date Error 3 3
Fracture 3 3
Excess Flow or Over-Infusion 2 2
Defective Component 2 2
Volume Accuracy Problem 2 2
Material Twisted/Bent 2 2
Unexpected Color 2 2
Data Problem 2 2
Failure to Align 2 2
Tear, Rip or Hole in Device Packaging 2 2
Filling Problem 2 2
Degraded 1 1
Mechanical Jam 1 1
Sparking 1 1
Material Rupture 1 1
Application Program Freezes or Fails to Launch 1 1
Material Deformation 1 1
Corroded 1 1
Mechanical Problem 1 1
No Flow 1 1
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Free or Unrestricted Flow 1 1
Device Difficult to Program or Calibrate 1 1
Unintended Movement 1 1
Device Fell 1 1
Inaccurate Delivery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 346 349
Insufficient Information 24 24
No Patient Involvement 16 16
Hyperglycemia 6 6
Electrolyte Imbalance 3 3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
No Consequences Or Impact To Patient 2 2
Hyperkalemia 1 1
Dehydration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II May-29-2026
2 Baxter Healthcare Corporation I Jul-22-2022
3 OmniCell, Inc. II May-22-2023
4 Omnicell, Inc. I May-13-2026
5 Smiths Medical ASD Inc. II Apr-21-2021
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