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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 1
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 302 302

Device Problems MDRs with this Device Problem Events in those MDRs
Filling Problem 2239 2239
Fluid/Blood Leak 1995 2001
No Flow 956 956
Excess Flow or Over-Infusion 635 635
Material Rupture 503 503
Insufficient Flow or Under Infusion 269 269
Device Contamination with Chemical or Other Material 175 175
Break 123 125
Leak/Splash 113 123
Detachment of Device or Device Component 69 69
Failure to Infuse 67 67
Disconnection 65 65
Component Missing 61 61
Infusion or Flow Problem 59 59
Adverse Event Without Identified Device or Use Problem 59 61
Improper Flow or Infusion 55 55
Crack 52 54
Contamination /Decontamination Problem 47 47
Loose or Intermittent Connection 37 37
Material Split, Cut or Torn 26 26
Material Twisted/Bent 25 25
Inaccurate Flow Rate 19 19
Backflow 15 15
Material Puncture/Hole 14 14
Material Deformation 13 13
Failure to Prime 11 11
Complete Blockage 10 10
Air/Gas in Device 9 9
Pumping Problem 8 8
Physical Resistance/Sticking 8 8
Obstruction of Flow 8 8
Output below Specifications 8 8
Priming Problem 6 6
Failure to Deliver 6 6
Material Integrity Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Use of Device Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Device Contaminated During Manufacture or Shipping 5 5
Defective Device 4 4
Material Fragmentation 4 4
Precipitate in Device or Device Ingredient 4 4
Melted 3 3
Inaccurate Delivery 3 3
Fracture 3 4
Inadequate Instructions for Healthcare Professional 3 3
Degraded 3 3
Incomplete or Inadequate Connection 3 3
Failure to Deflate 2 2
Material Separation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6793 6801
Insufficient Information 173 182
No Consequences Or Impact To Patient 147 147
No Patient Involvement 88 88
Pain 42 43
Nausea 39 39
Discomfort 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Chemical Exposure 25 25
Numbness 21 21
Foreign Body In Patient 19 21
Tinnitus 15 15
Vomiting 14 14
Taste Disorder 11 11
Hot Flashes/Flushes 9 9
Inadequate Pain Relief 9 9
Diarrhea 9 9
Fever 9 10
Malaise 9 9
Bacterial Infection 8 9
Swelling/ Edema 8 10
Dyspnea 8 8
Abdominal Pain 8 8
Fatigue 7 7
Dizziness 6 6
Muscle Weakness 6 6
Chest Pain 6 6
High Blood Pressure/ Hypertension 6 6
Tachycardia 5 5
Diaphoresis 5 5
Peeling 4 4
Rash 4 4
Unspecified Kidney or Urinary Problem 3 3
Arrhythmia 3 3
Pulmonary Embolism 3 3
Lethargy 3 3
Purulent Discharge 3 3
Erythema 3 3
No Code Available 3 3
Blurred Vision 3 3
Visual Impairment 2 2
Balance Problems 2 2
Fall 2 2
Fluid Discharge 2 2
Alteration in Body Temperature 2 2
Foreign Body Embolism 2 2
Cough 2 2
Salivary Hypersecretion 2 2
Liver Damage/Dysfunction 2 2
Wound Dehiscence 2 2

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