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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 1293
2023 1248 1259
2024 1424 1424
2025 1208 1208

Device Problems MDRs with this Device Problem Events in those MDRs
Filling Problem 2832 2893
Fluid/Blood Leak 2774 3172
No Flow 1138 1151
Material Rupture 970 989
Excess Flow or Over-Infusion 654 655
Device Contamination with Chemical or Other Material 231 231
Infusion or Flow Problem 192 192
Break 169 173
Insufficient Flow or Under Infusion 162 162
Leak/Splash 103 114
Disconnection 97 97
Adverse Event Without Identified Device or Use Problem 78 78
Component Missing 69 71
Detachment of Device or Device Component 64 64
Improper Flow or Infusion 61 61
Crack 60 62
Contamination /Decontamination Problem 58 58
Failure to Infuse 54 55
Loose or Intermittent Connection 34 34
Inaccurate Flow Rate 33 33
Material Twisted/Bent 27 27
Material Split, Cut or Torn 26 26
Backflow 19 19
Material Deformation 16 16
Failure to Prime 14 14
Obstruction of Flow 9 9
Output below Specifications 8 8
Pumping Problem 8 8
Failure to Deliver 8 8
Physical Resistance/Sticking 7 7
Complete Blockage 7 7
Air/Gas in Device 7 7
Use of Device Problem 6 6
Defective Device 6 6
Fracture 6 7
Material Puncture/Hole 6 6
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
Therapeutic or Diagnostic Output Failure 4 4
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 6312 6318
No Patient Involvement 1606 1955
No Consequences Or Impact To Patient 1160 1195
Insufficient Information 172 181
No Known Impact Or Consequence To Patient 94 203
Pain 46 47
Nausea 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Discomfort 30 30
Numbness 27 27
Foreign Body In Patient 26 27
Chemical Exposure 24 24
No Code Available 21 21
Tinnitus 20 20
Malaise 17 17
Vomiting 17 17
Abdominal Pain 11 11
Taste Disorder 11 11
Fatigue 11 11
Fever 10 10
Diarrhea 10 10
Inadequate Pain Relief 10 10
Dyspnea 9 9
Hot Flashes/Flushes 9 9
Swelling/ Edema 8 8
Tachycardia 8 8
Bacterial Infection 8 8
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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