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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, enteral
Product CodeLZH
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
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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