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TPLC
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show TPLC since
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Device
accessories, pump, infusion
Product Code
MRZ
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
AIDERA AB
SUBSTANTIALLY EQUIVALENT
2
AMERICAN I.V. PRODUCTS, INC DBA AIV, INC
SUBSTANTIALLY EQUIVALENT
1
AMERICAN I.V. PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
B. BRAUN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
B. BRAUN MELSUGEN AG
SUBSTANTIALLY EQUIVALENT
1
CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ELITE BIOMEDICAL SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
GILERO, LLC
SUBSTANTIALLY EQUIVALENT
1
HOSPIRA, INC
SUBSTANTIALLY EQUIVALENT
1
ICU MEDICAL
SUBSTANTIALLY EQUIVALENT
1
IVWATCH, LLC
SUBSTANTIALLY EQUIVALENT
1
LIFESCAN, INC.
SUBSTANTIALLY EQUIVALENT
1
SMITHS MEDICAL MD, INC.
SUBSTANTIALLY EQUIVALENT
1
WELLDOC, INC
SUBSTANTIALLY EQUIVALENT
6
WELLDOC, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
117
117
2016
55
55
2017
18
18
2018
46
46
2019
36
36
2020
44
44
2021
59
59
2022
39
39
2023
27
27
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
139
139
Device Alarm System
42
42
Excess Flow or Over-Infusion
20
20
Adverse Event Without Identified Device or Use Problem
17
17
Power Problem
17
17
Fluid/Blood Leak
15
15
Thermal Decomposition of Device
14
14
Computer Software Problem
13
13
Infusion or Flow Problem
13
13
Patient Device Interaction Problem
13
13
Insufficient Flow or Under Infusion
12
12
Charging Problem
9
9
Protective Measures Problem
9
9
Mechanical Problem
9
9
Temperature Problem
8
8
Electrical /Electronic Property Problem
7
7
Smoking
6
6
Battery Problem
6
6
Device Issue
6
6
Device Displays Incorrect Message
5
5
Material Integrity Problem
5
5
Failure to Power Up
5
5
Leak/Splash
4
4
Melted
4
4
Failure to Charge
4
4
Volume Accuracy Problem
4
4
Air/Gas in Device
4
4
Packaging Problem
3
3
Appropriate Term/Code Not Available
3
3
Defective Device
3
3
Sparking
3
3
Improper Flow or Infusion
3
3
Device Contamination with Chemical or Other Material
3
3
Display or Visual Feedback Problem
3
3
Product Quality Problem
3
3
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Use of Device Problem
2
2
Overheating of Device
2
2
Difficult To Position
2
2
Failure to Prime
2
2
No Audible Alarm
2
2
Inaccurate Flow Rate
2
2
Crack
2
2
Free or Unrestricted Flow
2
2
Output Problem
2
2
Obstruction of Flow
2
2
Failure to Calibrate
2
2
Communication or Transmission Problem
2
2
Connection Problem
2
2
Activation, Positioning or Separation Problem
2
2
Insufficient Information
2
2
Key or Button Unresponsive/not Working
1
1
Failure to Eject
1
1
Physical Resistance/Sticking
1
1
Audible Prompt/Feedback Problem
1
1
Inadequate Lubrication
1
1
Detachment of Device or Device Component
1
1
Device Damaged by Another Device
1
1
Electrical Shorting
1
1
Failure to Auto Stop
1
1
Flare or Flash
1
1
Split
1
1
Arcing
1
1
Defective Component
1
1
Failure to Deliver
1
1
Inaccurate Delivery
1
1
Failure to Infuse
1
1
Therapeutic or Diagnostic Output Failure
1
1
Problem with Software Installation
1
1
Failure to Cycle
1
1
Difficult or Delayed Positioning
1
1
Corroded
1
1
Image Display Error/Artifact
1
1
Bent
1
1
Defective Alarm
1
1
Low Audible Alarm
1
1
Charred
1
1
Complete Blockage
1
1
Material Puncture/Hole
1
1
Inaccurate Synchronization
1
1
Device Inoperable
1
1
Failure to Sense
1
1
Material Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
111
111
No Consequences Or Impact To Patient
104
104
No Clinical Signs, Symptoms or Conditions
68
68
No Patient Involvement
58
58
Insufficient Information
48
48
Electric Shock
24
24
No Information
19
19
Pain
6
6
Erythema
5
5
Swelling/ Edema
5
5
Death
3
3
Loss of consciousness
3
3
Endocarditis
2
2
Hyperglycemia
2
2
High Blood Pressure/ Hypertension
2
2
Unspecified Infection
2
2
Overdose
2
2
Hypoglycemia
1
1
Fainting
1
1
Headache
1
1
Chemical Exposure
1
1
Blood Loss
1
1
Vomiting
1
1
Inadequate Pain Relief
1
1
No Code Available
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Animas Corporation
II
Dec-03-2009
2
ICU Medical Inc
II
Oct-14-2019
3
ICU Medical Inc
II
Dec-17-2018
4
Smiths Medical ASD Inc.
II
Apr-15-2024
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