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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
2
CARDINAL HEALTH LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1650
1650
2019
742
742
2020
1460
1460
2021
1218
1218
2022
526
526
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1775
1775
Protective Measures Problem
992
992
Excess Flow or Over-Infusion
471
471
No Audible Alarm
402
402
Failure to Deliver
243
243
No Display/Image
237
237
Loss of Power
222
222
Device Alarm System
159
159
Air/Gas in Device
138
138
Insufficient Flow or Under Infusion
132
132
Use of Device Problem
112
112
Infusion or Flow Problem
105
105
Inaccurate Flow Rate
99
99
Leak/Splash
96
96
Failure to Auto Stop
95
95
Detachment of Device or Device Component
90
90
Inaccurate Delivery
66
66
Display or Visual Feedback Problem
50
50
Thermal Decomposition of Device
43
43
Volume Accuracy Problem
40
40
Human-Device Interface Problem
36
36
Improper Flow or Infusion
34
34
Overheating of Device
22
22
Device Displays Incorrect Message
19
19
Delayed Alarm
17
17
Increased Pump Speed
16
16
Break
14
14
Decreased Pump Speed
13
13
Improper or Incorrect Procedure or Method
12
12
Detachment Of Device Component
12
12
Defective Device
9
9
Appropriate Term/Code Not Available
9
9
Failure to Power Up
8
8
Material Separation
7
7
Obstruction of Flow
7
7
Fire
7
7
Mechanical Problem
6
6
Melted
6
6
Material Puncture/Hole
6
6
Electrical Power Problem
6
6
Battery Problem
6
6
Free or Unrestricted Flow
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Electrical /Electronic Property Problem
5
5
Incorrect Measurement
5
5
Crack
4
4
Defective Alarm
4
4
Pumping Stopped
4
4
Defective Component
4
4
Occlusion Within Device
3
3
Display Difficult to Read
3
3
Output Problem
3
3
Temperature Problem
3
3
Device Dislodged or Dislocated
3
3
Sparking
3
3
Device Operates Differently Than Expected
3
3
Electrical Shorting
2
2
Failure of Device to Self-Test
2
2
Failure to Shut Off
2
2
Device Contamination with Chemical or Other Material
2
2
Therapeutic or Diagnostic Output Failure
2
2
Pumping Problem
2
2
Application Program Problem: Medication Error
2
2
Power Problem
2
2
Insufficient Information
2
2
Noise, Audible
2
2
Patient Device Interaction Problem
2
2
Device Fell
2
2
Unintended Electrical Shock
2
2
Application Program Problem: Dose Calculation Error
2
2
Unintended Ejection
2
2
Flushing Problem
2
2
Hole In Material
2
2
Alarm Not Visible
2
2
Use of Incorrect Control/Treatment Settings
2
2
Device Emits Odor
2
2
Difficult to Remove
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Material Rupture
2
2
Incorrect Or Inadequate Test Results
2
2
Failure to Infuse
2
2
Device Issue
2
2
Inadequate or Insufficient Training
2
2
Inappropriate/Inadequate Shock/Stimulation
1
1
Short Fill
1
1
No Audible Prompt/Feedback
1
1
Component Missing
1
1
Self-Activation or Keying
1
1
Product Quality Problem
1
1
Device Remains Activated
1
1
Moisture Damage
1
1
Device Difficult to Program or Calibrate
1
1
Corroded
1
1
Disconnection
1
1
Component Falling
1
1
Computer Software Problem
1
1
Burst Container or Vessel
1
1
Complete Blockage
1
1
Failure To Adhere Or Bond
1
1
Partial Blockage
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1799
1799
No Consequences Or Impact To Patient
1577
1577
No Patient Involvement
1189
1189
No Known Impact Or Consequence To Patient
690
690
No Information
209
209
Insufficient Information
92
92
Vomiting
29
29
Dyskinesia
19
19
Ambulation Difficulties
14
14
Nausea
14
14
Abdominal Distention
13
13
Discomfort
13
13
Overdose
8
8
No Code Available
6
6
Muscle Spasm(s)
6
6
Shaking/Tremors
6
6
Cognitive Changes
6
6
Anxiety
5
5
Pain
5
5
Hypoglycemia
5
5
Device Overstimulation of Tissue
5
5
Feeding Problem
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Dyspnea
4
4
Death
4
4
Urinary Retention
4
4
Sleep Dysfunction
4
4
Fatigue
3
3
Tachycardia
3
3
Electric Shock
3
3
Weight Changes
3
3
Abdominal Pain
3
3
Malaise
3
3
Abdominal Cramps
2
2
Fall
2
2
Aspiration/Inhalation
2
2
Twitching
2
2
Distress
2
2
Complaint, Ill-Defined
2
2
Weakness
2
2
Flatus
2
2
Dementia
2
2
Visual Disturbances
2
2
Lethargy
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Sepsis
1
1
Fever
1
1
Hypernatremia
1
1
Pressure Sores
1
1
Sudden Cardiac Death
1
1
Dysphasia
1
1
Respiratory Distress
1
1
Unspecified Infection
1
1
Undesired Nerve Stimulation
1
1
Chest Pain
1
1
Headache
1
1
Blood Loss
1
1
Inadequate Pain Relief
1
1
Mitral Valve Prolapse
1
1
Confusion/ Disorientation
1
1
Patient Problem/Medical Problem
1
1
Not Applicable
1
1
Hyperglycemia
1
1
Muscular Rigidity
1
1
Constipation
1
1
Gastrointestinal Regurgitation
1
1
Burn(s)
1
1
Loss of Range of Motion
1
1
Swelling
1
1
Neurological Deficit/Dysfunction
1
1
Convulsion/Seizure
1
1
Low Oxygen Saturation
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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