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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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 72 72
Fluid/Blood Leak 67 67
Application Program Problem: Dose Calculation Error 35 35
Application Program Problem 31 32
Disconnection 30 30
Inadequate User Interface 25 26
Product Quality Problem 25 26
Device Contamination with Chemical or Other Material 18 18
Leak/Splash 13 13
Difficult to Open or Close 10 10
Crack 10 10
Defective Component 10 10
Contamination 9 9
Air/Gas in Device 8 8
Material Split, Cut or Torn 7 7
Loose or Intermittent Connection 7 7
Contamination of Device Ingredient or Reagent 7 7
Precipitate in Device or Device Ingredient 7 7
Component Missing 7 7
Unexpected Shutdown 6 6
Detachment of Device or Device Component 5 5
Microbial Contamination of Device 5 5
Output Problem 4 4
Wireless Communication Problem 4 4
Device Emits Odor 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Fail-Safe Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Fracture 3 3
Labelling, Instructions for Use or Training Problem 3 3
Expiration Date Error 3 3
Contamination /Decontamination Problem 3 3
Application Program Problem: Medication Error 3 3
Corroded 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Tear, Rip or Hole in Device Packaging 2 2
Unexpected Color 2 2
Data Problem 2 2
Excess Flow or Over-Infusion 2 2
Material Twisted/Bent 2 2
Failure to Align 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Device 2 2
Filling Problem 2 2
Device Markings/Labelling Problem 2 2
Device Alarm System 2 2
Volume Accuracy Problem 2 2
Material Fragmentation 1 2
Degraded 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 324 327
Insufficient Information 24 24
No Patient Involvement 16 16
Hyperglycemia 6 6
Electrolyte Imbalance 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Consequences Or Impact To Patient 2 2
Dehydration 1 1

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