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TPLC
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Device
pump, infusion, enteral
Product Code
LZH
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
AMSINO INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
2620
2620
2018
1650
1650
2019
742
742
2020
1460
1460
2021
1218
1218
2022
246
246
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid Leak
1787
1787
No Audible Alarm
852
852
Protective Measures Problem
817
817
No Display/Image
805
805
Excess Flow or Over-Infusion
623
623
Loss of Power
576
576
Device Alarm System
249
249
Failure to Deliver
212
212
Insufficient Flow or Under Infusion
211
211
Leak/Splash
209
209
Volume Accuracy Problem
168
168
Inaccurate Flow Rate
163
163
Failure to Auto Stop
141
141
Thermal Decomposition of Device
135
135
Infusion or Flow Problem
123
123
Air/Gas in Device
123
123
Detachment of Device or Device Component
120
120
Use of Device Problem
118
118
Inaccurate Delivery
104
104
Display or Visual Feedback Problem
102
102
Device Operates Differently Than Expected
59
59
Improper Flow or Infusion
53
53
Device Displays Incorrect Message
43
43
Device Stops Intermittently
38
38
Detachment Of Device Component
38
38
Human-Device Interface Problem
36
36
Delayed Alarm
34
34
Overheating of Device
32
32
Break
30
30
Failure to Power Up
24
24
Decreased Pump Speed
24
24
Increased Pump Speed
24
24
Defective Alarm
23
23
Defective Component
15
15
Improper or Incorrect Procedure or Method
14
14
Self-Activation or Keying
14
14
Occlusion Within Device
13
13
Appropriate Term/Code Not Available
13
13
Power Problem
13
13
Disconnection
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Poor Quality Image
9
9
Defective Device
9
9
Obstruction of Flow
9
9
Incorrect Or Inadequate Test Results
9
9
Incorrect Measurement
8
8
Mechanical Problem
8
8
Fire
8
8
Melted
7
7
Unable to Obtain Readings
7
7
Material Separation
7
7
Electrical Power Problem
7
7
Battery Problem
6
6
Pumping Stopped
6
6
Material Puncture/Hole
6
6
Hole In Material
6
6
Electrical /Electronic Property Problem
6
6
Crack
6
6
Pumping Problem
6
6
Temperature Problem
5
5
Output Problem
5
5
Device Handling Problem
5
5
Noise, Audible
5
5
Use of Incorrect Control Settings
5
5
Image Display Error/Artifact
5
5
Sparking
5
5
Free or Unrestricted Flow
5
5
Failure to Shut Off
4
4
Failure of Device to Self-Test
4
4
Device Issue
4
4
Smoking
4
4
Failure to Prime
4
4
Incorrect, Inadequate or Imprecise Resultor Readings
4
4
Material Rupture
4
4
Display Difficult to Read
4
4
Insufficient Information
4
4
Output below Specifications
3
3
Erratic or Intermittent Display
3
3
Corroded
3
3
Flushing Problem
3
3
Alarm Not Visible
3
3
Complete Blockage
3
3
Power Conditioning Problem
3
3
Output above Specifications
3
3
Device Inoperable
3
3
Inaudible or Unclear Audible Prompt/Feedback
3
3
Failure to Infuse
3
3
Failure to Disconnect
3
3
Calibration Problem
3
3
Delivery System Failure
3
3
Device Dislodged or Dislocated
3
3
Electrical Shorting
2
2
Device Contamination with Chemical or Other Material
2
2
Device Operational Issue
2
2
Contamination of Device Ingredient or Reagent
2
2
Issue With Displayed Error Message
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Integrity Problem
2
2
Inadequate or Insufficient Training
2
2
Failure to Sense
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
2341
2341
No Consequences Or Impact To Patient
2098
2098
No Clinical Signs, Symptoms or Conditions
1523
1523
No Known Impact Or Consequence To Patient
1369
1369
No Information
474
474
Insufficient Information
92
92
Vomiting
28
28
Dyskinesia
21
21
Not Applicable
20
20
Overdose
16
16
Nausea
14
14
Ambulation Difficulties
14
14
Discomfort
13
13
Abdominal Distention
12
12
No Code Available
10
10
Cognitive Changes
6
6
Shaking/Tremors
6
6
Muscle Spasm(s)
6
6
Feeding Problem
6
6
Hypoglycemia
5
5
Device Overstimulation of Tissue
5
5
Pain
5
5
Anxiety
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Sleep Dysfunction
4
4
Urinary Retention
4
4
Flatus
4
4
Death
4
4
Dyspnea
4
4
Abdominal Pain
3
3
Fatigue
3
3
Tachycardia
3
3
Malaise
3
3
Electric Shock
3
3
Weight Changes
3
3
Abdominal Cramps
2
2
Distress
2
2
Weakness
2
2
Twitching
2
2
Complaint, Ill-Defined
2
2
Loss of consciousness
2
2
Hyperglycemia
2
2
Visual Disturbances
2
2
Unspecified Infection
2
2
Fall
2
2
Dementia
2
2
Aspiration/Inhalation
1
1
Burn(s)
1
1
Chest Pain
1
1
Headache
1
1
Muscle Stimulation
1
1
Fever
1
1
Muscular Rigidity
1
1
Undesired Nerve Stimulation
1
1
Neurological Deficit/Dysfunction
1
1
Pneumonia
1
1
Pneumothorax
1
1
Loss of Range of Motion
1
1
Respiratory Distress
1
1
Sepsis
1
1
Swelling
1
1
Mitral Valve Prolapse
1
1
Low Oxygen Saturation
1
1
Sudden Cardiac Death
1
1
Inadequate Pain Relief
1
1
Dysphasia
1
1
Tingling
1
1
Hypernatremia
1
1
Pressure Sores
1
1
Underdose
1
1
Lethargy
1
1
Blood Loss
1
1
Confusion/ Disorientation
1
1
Patient Problem/Medical Problem
1
1
Constipation
1
1
Convulsion/Seizure
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Gastrointestinal Regurgitation
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
II
Apr-02-2021
2
Cardinal Health 200, LLC
II
Nov-13-2020
3
Cardinal Health Inc.
II
May-22-2020
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