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TPLC
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show TPLC since
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Device
pump, infusion, enteral
Product Code
LZH
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACACIA, INC.
SUBSTANTIALLY EQUIVALENT
1
AMSINO INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
2
CARDINAL HEALTH LLC
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
3
VESCO MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
ZEVEX, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
116
116
2015
83
83
2016
1248
1248
2017
2620
2620
2018
1651
1651
2019
742
742
2020
1460
1460
2021
1218
1218
2022
526
526
2023
284
284
2024
207
207
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1843
1843
Protective Measures Problem
1328
1328
No Audible Alarm
961
961
No Display/Image
831
831
Excess Flow or Over-Infusion
744
744
Loss of Power
671
671
Device Alarm System
364
364
Failure to Deliver
350
350
Insufficient Flow or Under Infusion
324
324
Leak/Splash
237
237
Air/Gas in Device
221
221
Device Operates Differently Than Expected
208
208
Inaccurate Delivery
195
195
Inaccurate Flow Rate
185
185
Failure to Auto Stop
183
183
Thermal Decomposition of Device
178
178
Volume Accuracy Problem
178
178
Infusion or Flow Problem
166
166
Detachment of Device or Device Component
125
125
Use of Device Problem
122
122
Display or Visual Feedback Problem
113
113
Device Displays Incorrect Message
100
100
Mechanical Problem
89
89
Break
85
85
Device Stops Intermittently
79
79
Detachment Of Device Component
76
76
Improper Flow or Infusion
76
76
Failure to Power Up
58
58
Defective Alarm
57
57
Overheating of Device
40
40
Disconnection
39
39
Occlusion Within Device
39
39
Human-Device Interface Problem
36
36
Delayed Alarm
34
34
Pumping Problem
31
31
Increased Pump Speed
29
29
Self-Activation or Keying
27
27
Decreased Pump Speed
25
25
Defective Component
21
21
Connection Problem
20
20
Pumping Stopped
18
18
Improper or Incorrect Procedure or Method
18
18
Power Problem
18
18
Defective Device
17
17
Melted
17
17
Failure to Charge
17
17
No Flow
16
16
Fire
15
15
Battery Problem
15
15
Smoking
15
15
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
2542
2542
No Known Impact Or Consequence To Patient
2360
2360
No Clinical Signs, Symptoms or Conditions
2263
2263
No Consequences Or Impact To Patient
2176
2176
No Information
548
548
Insufficient Information
102
102
Vomiting
47
47
No Code Available
45
45
Hypoglycemia
26
27
Dyskinesia
22
22
Not Applicable
21
21
Overdose
21
21
Feeding Problem
18
18
Nausea
16
16
Abdominal Distention
16
16
Ambulation Difficulties
14
14
Discomfort
14
14
Death
12
12
Weight Changes
7
7
Abdominal Pain
7
7
Pain
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Shaking/Tremors
6
6
Muscle Spasm(s)
6
6
Flatus
6
6
Cognitive Changes
6
6
Underdose
5
5
Anxiety
5
5
Dyspnea
5
5
Missed Dose
5
5
Device Overstimulation of Tissue
5
5
Sleep Dysfunction
4
4
Electric Shock
4
4
Aspiration/Inhalation
4
4
Urinary Retention
4
4
Tachycardia
3
3
Pneumonia
3
3
Hyperglycemia
3
4
Burn(s)
3
3
Malaise
3
3
Fatigue
3
3
Unspecified Infection
3
3
Complaint, Ill-Defined
3
3
Lethargy
2
2
Distress
2
2
Weakness
2
2
Fever
2
2
Visual Disturbances
2
2
Dementia
2
2
Abdominal Cramps
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Nutrition, Abbott Laboratories
II
Sep-21-2009
2
CORPAK MedSystems
II
Oct-25-2011
3
Cardinal Health 200, LLC
II
Apr-02-2021
4
Cardinal Health 200, LLC
II
Nov-13-2020
5
Cardinal Health Inc.
II
May-22-2020
6
MOOG Medical Devices Group
II
Jan-31-2013
7
MOOG Medical Devices Group
II
Nov-15-2012
8
Medtronic
II
May-10-2016
9
Zevex International, Inc.
II
Sep-21-2009
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