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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
2020 2732 3226
2021 1802 1802
2022 1288 1295
2023 1248 1261
2024 1424 1425
2025 1434 1434

Device Problems MDRs with this Device Problem Events in those MDRs
Filling Problem 2845 2906
Fluid/Blood Leak 2839 3238
No Flow 1164 1177
Material Rupture 984 1003
Excess Flow or Over-Infusion 678 679
Device Contamination with Chemical or Other Material 236 236
Insufficient Flow or Under Infusion 211 211
Infusion or Flow Problem 194 194
Break 172 178
Leak/Splash 109 120
Disconnection 98 98
Adverse Event Without Identified Device or Use Problem 78 80
Component Missing 73 75
Failure to Infuse 68 69
Detachment of Device or Device Component 67 67
Improper Flow or Infusion 61 61
Crack 60 62
Contamination /Decontamination Problem 58 58
Loose or Intermittent Connection 36 36
Inaccurate Flow Rate 33 33
Material Twisted/Bent 28 28
Material Split, Cut or Torn 26 26
Backflow 20 20
Material Deformation 16 16
Failure to Prime 14 14
Complete Blockage 10 10
Obstruction of Flow 9 9
Output below Specifications 8 8
Physical Resistance/Sticking 8 8
Pumping Problem 8 8
Failure to Deliver 8 8
Air/Gas in Device 7 7
Use of Device Problem 6 6
Defective Device 6 6
Fracture 6 7
Material Puncture/Hole 6 6
Therapeutic or Diagnostic Output Failure 5 5
Material Integrity Problem 5 5
Precipitate in Device or Device Ingredient 5 5
Priming Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Fragmentation 4 4
Material Separation 3 3
Degraded 3 3
Defective Component 3 3
Inaccurate Delivery 3 3
Melted 3 3
Product Quality Problem 2 3
Failure to Deflate 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6529 6537
No Patient Involvement 1606 1955
No Consequences Or Impact To Patient 1160 1195
Insufficient Information 175 184
No Known Impact Or Consequence To Patient 94 203
Pain 47 49
Nausea 44 44
Discomfort 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Numbness 27 27
Foreign Body In Patient 26 28
Chemical Exposure 25 25
No Code Available 21 21
Tinnitus 20 20
Vomiting 18 18
Malaise 17 17
Fatigue 12 12
Abdominal Pain 11 11
Fever 11 12
Diarrhea 11 11
Taste Disorder 11 11
Dyspnea 10 10
Inadequate Pain Relief 10 10
Hot Flashes/Flushes 9 9
Swelling/ Edema 8 10
Tachycardia 8 8
Bacterial Infection 8 9
Dizziness 8 8
High Blood Pressure/ Hypertension 8 8
Chest Pain 7 7
Muscle Weakness 6 6
Diaphoresis 5 5
Swelling 5 5
Overdose 5 5
Thromboembolism 4 4
Peeling 4 4
Chills 4 4
Rash 4 4
Low Blood Pressure/ Hypotension 3 3
Hemorrhage/Bleeding 3 3
Pulmonary Embolism 3 3
Lethargy 3 3
Erythema 3 3
Unspecified Kidney or Urinary Problem 3 3
Purulent Discharge 3 3
Edema 3 3
Arrhythmia 3 3
Shaking/Tremors 3 3
Blurred Vision 3 3
Visual Impairment 3 3

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