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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, elastomeric
Regulation Description Infusion pump.
Product CodeMEB
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
EPIC MEDICAL PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 2
FIRST MEDICAL SOURCE, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1802 1802
2022 1288 1295
2023 1248 1261
2024 1424 1425
2025 1434 1434
2026 809 809

Device Problems MDRs with this Device Problem Events in those MDRs
Filling Problem 2263 2263
Fluid/Blood Leak 2122 2123
No Flow 996 996
Excess Flow or Over-Infusion 677 677
Material Rupture 532 532
Insufficient Flow or Under Infusion 353 353
Device Contamination with Chemical or Other Material 186 186
Break 122 124
Leak/Splash 97 97
Failure to Infuse 78 78
Detachment of Device or Device Component 70 70
Disconnection 62 62
Component Missing 62 62
Adverse Event Without Identified Device or Use Problem 59 61
Crack 52 52
Improper Flow or Infusion 50 50
Infusion or Flow Problem 47 47
Contamination /Decontamination Problem 46 46
Loose or Intermittent Connection 38 38
Material Twisted/Bent 27 27
Material Split, Cut or Torn 25 25
Backflow 18 18
Material Puncture/Hole 14 14
Material Deformation 13 13
Failure to Prime 11 11
Complete Blockage 10 10
Air/Gas in Device 10 10
Obstruction of Flow 9 9
Physical Resistance/Sticking 8 8
Material Integrity Problem 6 6
Priming Problem 6 6
Improper or Incorrect Procedure or Method 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Fragmentation 4 4
Precipitate in Device or Device Ingredient 4 4
Degraded 3 3
Material Separation 3 3
Contamination 3 3
Fracture 3 3
Melted 3 3
Insufficient Device Problem Information 3 3
Inaccurate Flow Rate 3 3
Incomplete or Inadequate Connection 3 3
Device Damaged Prior to Receipt by User 2 2
Device Dislodged or Dislocated 2 2
Use of Incorrect Control/Treatment Settings 2 2
Use of Device Problem 2 2
Scratched Material 2 2
Inadequate Instructions for Healthcare Professional 2 2
Short Fill 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7261 7269
Insufficient Information 179 188
No Consequences Or Impact To Patient 147 147
No Patient Involvement 88 88
Pain 43 44
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 41 41
Nausea 41 41
Discomfort 36 36
Chemical Exposure 26 26
Numbness 22 22
Foreign Body In Patient 20 22
Vomiting 16 16
Tinnitus 15 15
Taste Disorder 11 11
Diarrhea 10 10
Fatigue 10 10
Inadequate Pain Relief 9 9
Hot Flashes/Flushes 9 9
Fever 9 10
Dyspnea 9 9
Malaise 9 9
Abdominal Pain 8 8
Bacterial Infection 8 9
Swelling/ Edema 8 10
Muscle Weakness/Atrophy 7 7
Dizziness 7 7
High Blood Pressure/ Hypertension 6 6
Chest Pain 6 6
Diaphoresis 5 5
Tachycardia 5 5
Rash 4 4
Peeling 4 4
Unspecified Kidney or Urinary Problem 4 4
Headache 4 4
Purulent Discharge 3 3
Blurred Vision 3 3
Foreign Body Embolism 3 3
No Code Available 3 3
Arrhythmia 3 3
Erythema 3 3
Pulmonary Embolism 3 3
Lethargy 3 3
Balance Problems 2 2
Visual Impairment 2 2
Fluid Discharge 2 2
Cough 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Fall 2 2
Salivary Hypersecretion 2 2
Alteration in Body Temperature 2 2

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