Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
3
B. BRAUN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
BAXA CORP.
SUBSTANTIALLY EQUIVALENT
1
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
2
BD MEDICAL-MEDICAL SURGICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
CAREFUSION
SUBSTANTIALLY EQUIVALENT
1
CARMEL PHARMA AB.
SUBSTANTIALLY EQUIVALENT
3
DUOJECT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
EQUASHIELD MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
EXELINT INTERNATIONAL CO.
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
SUBSTANTIALLY EQUIVALENT
1
GCMEDICA ENTERPRISE LTD., (WUXI)
SUBSTANTIALLY EQUIVALENT
1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
HOSPIRA, INC.
SUBSTANTIALLY EQUIVALENT
1
ICU MEDICAL
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL MEDICAL INDUSTRIES INC.
SUBSTANTIALLY EQUIVALENT
1
INVIRO MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
IPAX, INC
SUBSTANTIALLY EQUIVALENT
1
JIANGSU CAINA MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
KIRO ROBOTICS S.L.
SUBSTANTIALLY EQUIVALENT
1
LABORATORIOS GRIFOLS, S.A.
SUBSTANTIALLY EQUIVALENT
3
MEDIMOP MEDICAL PROJECT LTD.
SUBSTANTIALLY EQUIVALENT
2
MEDIMOP MEDICAL PROJECTS LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDIMOP MEDICAL PROJECTS, LTD.
SUBSTANTIALLY EQUIVALENT
3
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDSOURCE INTERNATIONAL, LLC.
SUBSTANTIALLY EQUIVALENT
3
NIPRO MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OMNICELL, INC.
SUBSTANTIALLY EQUIVALENT
1
PHARMC, LLC
SUBSTANTIALLY EQUIVALENT
1
PLASTMED, LTD.
SUBSTANTIALLY EQUIVALENT
2
SFM MEDICAL DEVICES GMBH
SUBSTANTIALLY EQUIVALENT
2
SHANGHAI JINTA MEDICAL CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI LING FU TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SOL-MILLENNIUM MEDICAL GROUP
SUBSTANTIALLY EQUIVALENT
1
WEST PHARMA SERVICES IL, LTD.
SUBSTANTIALLY EQUIVALENT
5
WEST PHARMACEUTICAL SERVICES AZ, INC.
SUBSTANTIALLY EQUIVALENT
1
YUKON MEDICAL
SUBSTANTIALLY EQUIVALENT
2
YUKON MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
4
MDR Year
MDR Reports
MDR Events
2014
155
155
2015
126
126
2016
219
219
2017
533
533
2018
1497
1497
2019
1633
1789
2020
1167
1167
2021
923
923
2022
1836
1836
2023
1048
1048
2024
208
208
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
5045
5133
Device Contamination with Chemical or Other Material
1637
1699
Leak/Splash
381
381
Device Displays Incorrect Message
256
256
Infusion or Flow Problem
221
221
Break
202
202
Protective Measures Problem
139
139
Disconnection
136
141
Material Puncture/Hole
124
124
Defective Device
119
119
Contamination /Decontamination Problem
117
117
Defective Component
84
84
Device Alarm System
81
81
Nonstandard Device
76
76
Device Operates Differently Than Expected
74
74
Free or Unrestricted Flow
74
74
Output Problem
64
64
Air/Gas in Device
63
63
Hole In Material
53
53
Detachment of Device or Device Component
50
50
Therapeutic or Diagnostic Output Failure
49
49
Difficult to Open or Close
36
36
Improper Flow or Infusion
35
35
No Flow
35
35
Insufficient Information
33
33
Material Rupture
31
31
Crack
31
31
Connection Problem
30
30
Contamination
28
28
Loose or Intermittent Connection
28
28
Display or Visual Feedback Problem
26
26
Tear, Rip or Hole in Device Packaging
26
26
Component Missing
22
22
Unsealed Device Packaging
22
24
Chemical Spillage
21
21
Detachment Of Device Component
20
20
Material Separation
19
19
Material Perforation
18
18
Failure to Align
18
18
Excess Flow or Over-Infusion
18
18
Pressure Problem
16
16
Material Split, Cut or Torn
15
15
Product Quality Problem
15
15
Fitting Problem
15
15
Device Markings/Labelling Problem
14
14
Particulates
14
14
Delivered as Unsterile Product
14
14
Filling Problem
14
14
Device Difficult to Setup or Prepare
13
13
Material Twisted/Bent
13
13
Material Deformation
13
13
Use of Device Problem
13
13
Noise, Audible
13
13
Illegible Information
12
12
Backflow
12
12
Complete Blockage
11
11
Failure to Prime
11
11
Pumping Stopped
11
11
Insufficient Flow or Under Infusion
11
11
Material Integrity Problem
11
11
Gas/Air Leak
11
11
Increase in Pressure
10
10
Patient Device Interaction Problem
10
10
Packaging Problem
10
10
Material Opacification
9
9
Mechanical Problem
9
9
Misassembled
9
9
Material Discolored
9
9
Adverse Event Without Identified Device or Use Problem
9
9
Device Packaging Compromised
9
9
Improper or Incorrect Procedure or Method
9
9
Inaccurate Delivery
9
9
Obstruction of Flow
8
8
Cut In Material
8
8
Device Contaminated During Manufacture or Shipping
8
8
Manufacturing, Packaging or Shipping Problem
7
7
Device Damaged Prior to Use
7
7
Volume Accuracy Problem
7
7
Precipitate in Device or Device Ingredient
7
7
Pumping Problem
7
7
Activation Failure
6
6
Incomplete or Inadequate Connection
6
6
Priming Problem
6
6
Device Slipped
6
6
Failure to Infuse
6
6
Material Protrusion/Extrusion
6
6
Device Dislodged or Dislocated
5
5
Structural Problem
5
5
Reflux within Device
5
6
Inflation Problem
5
5
Air Leak
5
5
Audible Prompt/Feedback Problem
5
5
Appropriate Term/Code Not Available
5
5
Scratched Material
4
4
Defective Alarm
4
4
Partial Blockage
4
7
Component Falling
4
4
Labelling, Instructions for Use or Training Problem
4
4
Misconnection
4
4
Failure to Deliver
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
4074
4170
No Clinical Signs, Symptoms or Conditions
3229
3229
No Consequences Or Impact To Patient
629
633
No Known Impact Or Consequence To Patient
619
675
Insufficient Information
480
480
No Information
80
80
Dyspnea
33
33
Headache
28
28
Chemical Exposure
23
23
No Code Available
19
19
Dizziness
16
16
Pain
16
16
Fatigue
11
11
Diarrhea
11
11
Nausea
10
10
Unspecified Infection
9
9
Fever
9
9
Chest Pain
8
8
Malaise
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Hemorrhage/Bleeding
7
7
Hot Flashes/Flushes
4
4
Swelling/ Edema
4
4
Underdose
3
3
Unspecified Respiratory Problem
3
3
Vomiting
3
3
Tachycardia
3
3
Anxiety
3
3
Cough
3
3
Blood Loss
3
3
Arrhythmia
3
3
Exposure to Body Fluids
2
2
Abdominal Pain
2
2
Purulent Discharge
2
2
Hypoglycemia
2
2
Low Blood Pressure/ Hypotension
2
2
Hypoxia
2
2
Itching Sensation
2
2
Laceration(s)
2
2
Eye Injury
2
2
Sepsis
2
2
Hypervolemia
2
2
Foreign Body In Patient
2
2
Syncope/Fainting
2
2
Electrolyte Imbalance
2
2
Needle Stick/Puncture
2
2
Premature Labor
2
2
Low Oxygen Saturation
2
2
Respiratory Insufficiency
2
2
Decreased Appetite
2
2
Peripheral Edema
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
Shaking/Tremors
1
1
Pallor
1
1
Diaphoresis
1
1
Discomfort
1
1
Injury
1
1
Arthralgia
1
1
Vertigo
1
1
Taste Disorder
1
1
Heart Failure/Congestive Heart Failure
1
1
Pulmonary Hypertension
1
1
Radiation Exposure, Unintended
1
1
Patient Problem/Medical Problem
1
1
Dysuria
1
1
Weight Changes
1
1
Thromboembolism
1
1
Skin Discoloration
1
1
Swelling
1
1
Pneumonia
1
1
Rash
1
1
Red Eye(s)
1
1
Muscle Weakness
1
1
Hypersensitivity/Allergic reaction
1
1
Corneal Abrasion
1
1
Erythema
1
1
Adult Respiratory Distress Syndrome
1
1
Anaphylactic Shock
1
1
Anemia
1
1
Cardiac Arrest
1
1
Stroke/CVA
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B. Braun Medical Inc
I
Nov-05-2010
2
B. Braun Medical, Inc.
II
Mar-07-2022
3
B. Braun Medical, Inc.
II
Jun-02-2016
4
B. Braun Medical, Inc.
II
Nov-27-2013
5
Baxa Corporation
II
Sep-06-2013
6
Baxa Corporation
II
Jul-18-2013
7
Baxa Corporation
II
Apr-13-2012
8
Baxa Corporation
II
Apr-12-2011
9
Baxa Corporation
II
Mar-23-2010
10
Baxter Corporation Englewood
I
Oct-06-2016
11
Baxter Healthcare Corp.
II
Jul-01-2014
12
Baxter Healthcare Corp.
II
Nov-26-2013
13
Baxter Healthcare Corp.
II
Sep-23-2011
14
Baxter Healthcare Corp.
II
May-25-2011
15
Baxter Healthcare Corp.
II
Feb-22-2011
16
Baxter Healthcare Corporation
I
Feb-16-2024
17
Baxter Healthcare Corporation
II
Aug-24-2022
18
Baxter Healthcare Corporation
II
Oct-21-2019
19
Baxter Healthcare Corporation
II
May-22-2018
20
Excelsior Medical Corp
II
Jul-16-2014
21
International Medical Industries, Inc.
II
Jan-07-2023
22
Medimop Medical Projects Ltd.
II
Mar-12-2018
23
Migada Inc.
II
May-06-2009
24
WEST PHARMA. SERVICES IL, LTD
I
Jan-28-2019
-
-