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TPLC
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Device
pump, infusion, elastomeric
Product Code
MEB
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
HALYARD HEALTH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
974
4421
2020
2731
3223
2021
1802
1802
2022
1288
1288
2023
1248
1248
2024
279
279
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
2353
5060
Filling Problem
2268
2740
Material Rupture
986
1288
No Flow
925
1178
Excess Flow or Over-Infusion
605
605
Infusion or Flow Problem
276
276
Device Contamination with Chemical or Other Material
182
331
Break
156
178
Disconnection
97
97
Adverse Event Without Identified Device or Use Problem
91
91
Leak/Splash
87
87
Component Missing
66
69
Failure to Infuse
65
65
Improper Flow or Infusion
53
53
Crack
50
54
Contamination /Decontamination Problem
44
44
Loose or Intermittent Connection
28
29
Inaccurate Flow Rate
26
26
Detachment of Device or Device Component
26
26
Insufficient Flow or Under Infusion
25
25
Material Split, Cut or Torn
23
24
Backflow
17
17
Failure to Deliver
15
15
Material Deformation
14
14
Material Twisted/Bent
14
14
Physical Resistance/Sticking
11
11
Failure to Prime
10
10
Pumping Problem
9
9
Improper or Incorrect Procedure or Method
7
7
Obstruction of Flow
7
7
Defective Component
6
6
Material Integrity Problem
6
6
Device Contaminated During Manufacture or Shipping
5
5
Defective Device
5
5
Use of Device Problem
5
5
Material Separation
5
5
Fracture
5
5
Material Puncture/Hole
5
8
Air/Gas in Device
5
5
Material Fragmentation
4
4
Deflation Problem
4
4
Inaccurate Delivery
4
4
Patient-Device Incompatibility
3
3
Degraded
3
3
Priming Problem
3
3
Scratched Material
3
3
Therapeutic or Diagnostic Output Failure
3
3
Insufficient Information
2
2
Appropriate Term/Code Not Available
2
2
Application Program Problem: Medication Error
2
2
Activation Problem
2
2
Burst Container or Vessel
2
2
Product Quality Problem
2
2
Reflux within Device
2
2
Precipitate in Device or Device Ingredient
2
2
Melted
2
2
Misconnection
2
2
Device Damaged Prior to Use
2
2
Shipping Damage or Problem
2
2
Inadequate or Insufficient Training
1
1
Off-Label Use
1
1
Failure to Pump
1
1
Malposition of Device
1
1
Microbial Contamination of Device
1
1
Fitting Problem
1
24
Material Perforation
1
1
Difficult to Open or Close
1
1
Device Dislodged or Dislocated
1
1
Filtration Problem
1
1
Inadequate User Interface
1
1
Gas/Air Leak
1
1
Human-Device Interface Problem
1
1
Moisture Damage
1
1
Delivered as Unsterile Product
1
4
Material Opacification
1
1
Particulates
1
1
Increase in Pressure
1
1
Inadequate Instructions for Healthcare Professional
1
1
Failure to Reset
1
1
Complete Blockage
1
1
Partial Blockage
1
1
Material Discolored
1
1
Inflation Problem
1
1
Restricted Flow rate
1
1
Unexpected Color
1
1
Patient Device Interaction Problem
1
1
Mechanical Jam
1
1
Failure to Eject
1
1
No Apparent Adverse Event
1
1
Output Problem
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4059
4059
No Patient Involvement
1894
3974
No Consequences Or Impact To Patient
1428
2260
No Known Impact Or Consequence To Patient
413
1440
Insufficient Information
146
146
Pain
53
53
Nausea
43
43
Numbness
34
34
No Code Available
33
33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
25
25
Foreign Body In Patient
25
25
Tinnitus
21
21
Chemical Exposure
20
20
Malaise
18
18
Vomiting
18
18
Fatigue
15
15
Abdominal Pain
14
14
Dizziness
14
14
No Information
13
13
Tachycardia
12
12
Hot Flashes/Flushes
11
11
Discomfort
11
11
Inadequate Pain Relief
10
10
Overdose
10
10
Diarrhea
10
10
Dyspnea
10
10
Fever
10
10
Chest Pain
9
9
Taste Disorder
9
9
High Blood Pressure/ Hypertension
7
7
Rash
7
7
Muscle Weakness
6
6
Diaphoresis
6
6
Lethargy
6
6
Swelling/ Edema
5
5
Swelling
5
5
Low Blood Pressure/ Hypotension
5
5
Inflammation
5
5
Death
5
5
Bacterial Infection
5
5
Blurred Vision
4
4
Chills
4
4
Burning Sensation
4
4
Nerve Damage
4
4
Underdose
4
4
Thromboembolism
4
4
Anxiety
4
4
Reaction
3
3
Device Embedded In Tissue or Plaque
3
3
Missed Dose
3
3
Unspecified Kidney or Urinary Problem
3
3
Peeling
3
3
Arrhythmia
3
3
Pulmonary Embolism
3
3
Hemorrhage/Bleeding
3
3
Edema
3
3
Fall
2
2
Purulent Discharge
2
2
Dysphagia/ Odynophagia
2
2
Seizures
2
2
Necrosis
2
2
Hematoma
2
2
Muscle Spasm(s)
2
2
Weakness
2
2
Tingling
2
2
Cramp(s) /Muscle Spasm(s)
2
2
Syncope/Fainting
2
2
Blister
2
2
Alteration in Body Temperature
2
2
Balance Problems
2
2
Foreign Body Embolism
2
2
Cough
2
2
Shaking/Tremors
2
2
Sleep Dysfunction
2
2
Partial thickness (Second Degree) Burn
2
2
Test Result
2
2
Decreased Sensitivity
2
2
Confusion/ Disorientation
2
2
Sweating
2
2
Ulcer
2
2
Injury
1
1
Arthralgia
1
1
Heart Failure
1
1
Rupture
1
1
Therapeutic Response, Decreased
1
1
Chest Tightness/Pressure
1
1
Low Oxygen Saturation
1
1
Disability
1
1
Impaired Healing
1
1
Ambulation Difficulties
1
1
Caustic/Chemical Burns
1
1
Ptosis
1
1
Gastrointestinal Hemorrhage
1
1
Unspecified Gastrointestinal Problem
1
1
Hyponatremia
1
1
Thrombosis/Thrombus
1
1
Heart Failure/Congestive Heart Failure
1
1
Pericarditis
1
1
Convulsion/Seizure
1
1
Constipation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Feb-25-2019
2
Leventon S. A. U.
II
Aug-23-2019
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