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TPLC
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Device
pump, infusion, elastomeric
Regulation Description
Infusion pump.
Product Code
MEB
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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