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TPLC
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Device
set, i.v. fluid transfer
Product Code
LHI
Regulation Number
880.5440
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVCARE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
AEA SRL
SUBSTANTIALLY EQUIVALENT
1
AVENIR PERFORMANCE EUROPEENNE MEDICAL (APEM)
SUBSTANTIALLY EQUIVALENT
2
AVENIR PERFORMANCE EUROPÉENNE MEDICAL (APEM)
SUBSTANTIALLY EQUIVALENT
1
B. BRAUN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
1
GCMEDICA ENTERPRISE LTD., (WUXI)
SUBSTANTIALLY EQUIVALENT
1
ICU MEDICAL
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL MEDICAL INDUSTRIES INC.
SUBSTANTIALLY EQUIVALENT
1
IPAX, INC
SUBSTANTIALLY EQUIVALENT
1
JIANGSU CAINA MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OMNICELL, INC.
SUBSTANTIALLY EQUIVALENT
1
SFM MEDICAL DEVICES GMBH
SUBSTANTIALLY EQUIVALENT
1
SOL-MILLENNIUM MEDICAL GROUP
SUBSTANTIALLY EQUIVALENT
1
WEST PHARMA SERVICES IL, LTD.
SUBSTANTIALLY EQUIVALENT
1
WEST PHARMACEUTICAL SERVICES AZ, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1497
1497
2019
1633
1789
2020
1167
1167
2021
929
929
2022
1834
1834
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
4077
4165
Device Contamination with Chemical or Other Material
983
1045
Leak/Splash
289
289
Device Displays Incorrect Message
252
252
Infusion or Flow Problem
211
211
Break
165
165
Protective Measures Problem
134
134
Material Puncture/Hole
107
107
Disconnection
98
103
Defective Device
98
98
Contamination /Decontamination Problem
92
92
Device Alarm System
79
79
Defective Component
75
75
Free or Unrestricted Flow
67
67
Output Problem
60
60
Nonstandard Device
60
60
Therapeutic or Diagnostic Output Failure
49
49
Difficult to Open or Close
34
34
Air/Gas in Device
31
31
Improper Flow or Infusion
26
26
No Flow
24
24
Detachment of Device or Device Component
24
24
Display or Visual Feedback Problem
24
24
Crack
23
23
Component Missing
20
20
Unsealed Device Packaging
19
21
Material Perforation
18
18
Loose or Intermittent Connection
18
18
Excess Flow or Over-Infusion
18
18
Insufficient Information
18
18
Failure to Align
16
16
Hole In Material
14
14
Filling Problem
13
13
Material Rupture
13
13
Material Split, Cut or Torn
13
13
Noise, Audible
12
12
Pumping Stopped
11
11
Fitting Problem
11
11
Contamination
11
11
Complete Blockage
10
10
Insufficient Flow or Under Infusion
10
10
Use of Device Problem
10
10
Material Deformation
10
10
Gas/Air Leak
10
10
Tear, Rip or Hole in Device Packaging
10
10
Device Markings/Labelling Problem
10
10
Device Operates Differently Than Expected
10
10
Connection Problem
10
10
Material Twisted/Bent
9
9
Patient Device Interaction Problem
9
9
Pressure Problem
9
9
Material Opacification
9
9
Misassembled
8
8
Product Quality Problem
8
8
Material Separation
8
8
Volume Accuracy Problem
7
7
Device Difficult to Setup or Prepare
7
7
Failure to Prime
7
7
Particulates
7
7
Backflow
7
7
Mechanical Problem
7
7
Pumping Problem
7
7
Material Integrity Problem
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Manufacturing, Packaging or Shipping Problem
6
6
Obstruction of Flow
6
6
Cut In Material
6
6
Delivered as Unsterile Product
6
6
Improper or Incorrect Procedure or Method
6
6
Precipitate in Device or Device Ingredient
6
6
Priming Problem
6
6
Increase in Pressure
5
5
Material Discolored
5
5
Structural Problem
5
5
Inaccurate Delivery
5
5
Appropriate Term/Code Not Available
5
5
Incomplete or Inadequate Connection
5
5
Packaging Problem
5
5
Material Protrusion/Extrusion
5
5
Device Contaminated During Manufacture or Shipping
4
4
Audible Prompt/Feedback Problem
4
4
Failure to Infuse
4
4
Failure to Deliver
4
4
Difficult or Delayed Activation
4
4
Inflation Problem
4
4
Partial Blockage
4
7
Defective Alarm
4
4
Device Slipped
4
4
Unable to Obtain Readings
3
3
Reflux within Device
3
4
Failure to Power Up
3
3
Labelling, Instructions for Use or Training Problem
3
3
False Alarm
3
3
Inaccurate Flow Rate
3
3
Device Damaged Prior to Use
3
3
Device Fell
3
3
Unexpected Shutdown
3
3
Scratched Material
3
3
Activation Failure
2
2
Component Misassembled
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
3374
3470
No Clinical Signs, Symptoms or Conditions
2063
2063
No Consequences Or Impact To Patient
561
565
Insufficient Information
439
439
No Known Impact Or Consequence To Patient
414
470
No Information
55
55
Dyspnea
29
29
Headache
21
21
No Code Available
16
16
Pain
13
13
Dizziness
10
10
Diarrhea
8
8
Fatigue
7
7
Chest Pain
7
7
Nausea
7
7
Hemorrhage/Bleeding
6
6
Malaise
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Chemical Exposure
5
5
Anxiety
3
3
Vomiting
3
3
Arrhythmia
3
3
Itching Sensation
2
2
Hot Flashes/Flushes
2
2
Tachycardia
2
2
Premature Labor
2
2
Low Oxygen Saturation
2
2
Swelling/ Edema
2
2
Underdose
2
2
Peripheral Edema
1
1
Shaking/Tremors
1
1
Blood Loss
1
1
Thromboembolism
1
1
Hypervolemia
1
1
Patient Problem/Medical Problem
1
1
Syncope/Fainting
1
1
Heart Failure/Congestive Heart Failure
1
1
Cough
1
1
Respiratory Insufficiency
1
1
Unspecified Respiratory Problem
1
1
Gastroesophageal Burn
1
1
Unspecified Gastrointestinal Problem
1
1
Skin Inflammation/ Irritation
1
1
Contact Dermatitis
1
1
Unspecified Tissue Injury
1
1
Decreased Appetite
1
1
Pallor
1
1
Diaphoresis
1
1
Discomfort
1
1
Arthralgia
1
1
Rash
1
1
Red Eye(s)
1
1
Skin Discoloration
1
1
Swelling
1
1
Muscle Weakness
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Exposure to Body Fluids
1
1
Cardiac Arrest
1
1
Abdominal Pain
1
1
Adult Respiratory Distress Syndrome
1
1
Purulent Discharge
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B. Braun Medical, Inc.
II
Mar-07-2022
2
Baxter Healthcare Corporation
II
Aug-24-2022
3
Baxter Healthcare Corporation
II
Oct-21-2019
4
Baxter Healthcare Corporation
II
May-22-2018
5
International Medical Industries, Inc.
II
Jan-07-2023
6
Medimop Medical Projects Ltd.
II
Mar-12-2018
7
WEST PHARMA. SERVICES IL, LTD
I
Jan-28-2019
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