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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 2731 3223
2021 1802 1802
2022 1288 1288
2023 1249 1249
2024 1427 1427
2025 135 135

Device Problems MDRs with this Device Problem Events in those MDRs
Filling Problem 2585 2646
Fluid/Blood Leak 2462 2855
No Flow 1010 1023
Material Rupture 939 958
Excess Flow or Over-Infusion 567 567
Device Contamination with Chemical or Other Material 200 200
Infusion or Flow Problem 187 187
Break 156 160
Disconnection 94 94
Leak/Splash 86 86
Adverse Event Without Identified Device or Use Problem 78 78
Component Missing 59 61
Contamination /Decontamination Problem 57 57
Crack 53 53
Improper Flow or Infusion 52 52
Detachment of Device or Device Component 50 50
Loose or Intermittent Connection 30 30
Failure to Infuse 29 29
Material Split, Cut or Torn 21 21
Material Twisted/Bent 20 20
Inaccurate Flow Rate 20 20
Backflow 19 19
Insufficient Flow or Under Infusion 18 18
Material Deformation 15 15
Failure to Prime 12 12
Obstruction of Flow 8 8
Pumping Problem 8 8
Physical Resistance/Sticking 7 7
Use of Device Problem 6 6
Fracture 6 6
Failure to Deliver 6 6
Air/Gas in Device 5 5
Priming Problem 5 5
Complete Blockage 5 5
Defective Device 5 5
Material Integrity Problem 5 5
Precipitate in Device or Device Ingredient 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Puncture/Hole 4 4
Material Fragmentation 4 4
Improper or Incorrect Procedure or Method 4 4
Degraded 3 3
Material Separation 3 3
Defective Component 3 3
Fail-Safe Problem 2 2
Application Program Problem: Medication Error 2 2
Melted 2 2
Reflux within Device 2 2
Scratched Material 2 2
Patient-Device Incompatibility 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5289 5289
No Patient Involvement 1606 1955
No Consequences Or Impact To Patient 1160 1195
Insufficient Information 153 153
No Known Impact Or Consequence To Patient 94 202
Pain 46 46
Nausea 42 42
Numbness 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Foreign Body In Patient 26 26
No Code Available 21 21
Chemical Exposure 21 21
Tinnitus 20 20
Discomfort 19 19
Malaise 17 17
Vomiting 17 17
Abdominal Pain 11 11
Fatigue 11 11
Taste Disorder 11 11
Fever 10 10
Hot Flashes/Flushes 9 9
Diarrhea 9 9
Dyspnea 9 9
Inadequate Pain Relief 9 9
Tachycardia 8 8
Swelling/ Edema 8 8
Dizziness 8 8
High Blood Pressure/ Hypertension 7 7
Chest Pain 7 7
Muscle Weakness 6 6
Swelling 5 5
Overdose 5 5
Diaphoresis 5 5
Bacterial Infection 5 5
Rash 4 4
Chills 4 4
Thromboembolism 4 4
Shaking/Tremors 3 3
Pulmonary Embolism 3 3
Lethargy 3 3
Arrhythmia 3 3
Purulent Discharge 3 3
Low Blood Pressure/ Hypotension 3 3
Peeling 3 3
Blurred Vision 3 3
Unspecified Kidney or Urinary Problem 3 3
Hemorrhage/Bleeding 3 3
Edema 3 3
Cramp(s) /Muscle Spasm(s) 2 2
Inflammation 2 2

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