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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
VESCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 742 742
2020 1460 1460
2021 1218 1218
2022 526 526
2023 284 284
2024 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1776 1776
Protective Measures Problem 1156 1156
Excess Flow or Over-Infusion 353 353
Failure to Deliver 254 254
Air/Gas in Device 213 213
Use of Device Problem 102 102
Infusion or Flow Problem 98 98
Insufficient Flow or Under Infusion 87 87
Detachment of Device or Device Component 87 87
Inaccurate Delivery 56 56
Failure to Auto Stop 52 52
Leak/Splash 47 47
Human-Device Interface Problem 35 35
Inaccurate Flow Rate 33 33
Improper Flow or Infusion 16 16
Break 14 14
Mechanical Problem 11 11
Device Alarm System 10 10
Defective Device 10 10
Improper or Incorrect Procedure or Method 9 9
Increased Pump Speed 9 9
Failure to Power Up 8 8
Fire 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Obstruction of Flow 7 7
Material Puncture/Hole 6 6
Material Separation 5 5
Disconnection 5 5
Battery Problem 5 5
Device Displays Incorrect Message 4 4
No Audible Alarm 4 4
Crack 4 4
Appropriate Term/Code Not Available 4 4
Electrical /Electronic Property Problem 3 3
Material Rupture 3 3
Free or Unrestricted Flow 3 3
Power Problem 2 2
Pumping Stopped 2 2
Electrical Power Problem 2 2
Flushing Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Fell 2 2
Patient Device Interaction Problem 2 2
Material Split, Cut or Torn 1 1
Complete Loss of Power 1 1
Unintended Electrical Shock 1 1
Program or Algorithm Execution Problem 1 1
Incomplete or Inadequate Connection 1 1
Priming Problem 1 1
Incomplete or Inadequate Priming 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Application Program Problem: Medication Error 1 1
Noise, Audible 1 1
Labelling, Instructions for Use or Training Problem 1 1
Unintended Ejection 1 1
Defective Alarm 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Computer Software Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Short Fill 1 1
Inadequate or Insufficient Training 1 1
Product Quality Problem 1 1
Device Remains Activated 1 1
Difficult to Remove 1 1
Failure to Prime 1 1
Device Difficult to Program or Calibrate 1 1
Failure to Pump 1 1
Melted 1 1
Failure to Run on Battery 1 1
Electrical Shorting 1 1
Fail-Safe Problem 1 1
Device Dislodged or Dislocated 1 1
Sparking 1 1
Contamination /Decontamination Problem 1 1
Failure to Infuse 1 1
Defective Component 1 1
Pumping Problem 1 1
Temperature Problem 1 1
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Packaging Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2144 2144
No Consequences Or Impact To Patient 1348 1348
No Known Impact Or Consequence To Patient 414 414
No Patient Involvement 124 124
Insufficient Information 99 99
No Information 74 74
Vomiting 34 34
Dyskinesia 15 15
Discomfort 14 14
Abdominal Distention 14 14
Ambulation Difficulties 14 14
Nausea 14 14
Feeding Problem 7 7
Hypoglycemia 7 7
Muscle Spasm(s) 6 6
Overdose 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Code Available 5 5
Cognitive Changes 5 5
Weight Changes 5 5
Shaking/Tremors 5 5
Anxiety 5 5
Abdominal Pain 5 5
Dyspnea 5 5
Urinary Retention 4 4
Device Overstimulation of Tissue 3 3
Pain 3 3
Death 3 3
Flatus 3 3
Fatigue 3 3
Sleep Dysfunction 3 3
Malaise 3 3
Tachycardia 3 3
Electric Shock 2 2
Lethargy 2 2
Abdominal Cramps 2 2
Dementia 2 2
Fever 2 2
Fall 2 2
Aspiration/Inhalation 2 2
Visual Disturbances 2 2
Distress 2 2
Twitching 2 2
Dysphasia 1 1
Electrolyte Imbalance 1 1
Weakness 1 1
Hypernatremia 1 1
Undesired Nerve Stimulation 1 1
Pneumonia 1 1
Loss of Range of Motion 1 1
Respiratory Distress 1 1
Swelling 1 1
Burn(s) 1 1
Arrhythmia 1 1
Dehydration 1 1
Headache 1 1
Hyperglycemia 1 1
Muscular Rigidity 1 1
Inadequate Pain Relief 1 1
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Blood Loss 1 1
Confusion/ Disorientation 1 1
Constipation 1 1
Convulsion/Seizure 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Gastrointestinal Regurgitation 1 1
Full thickness (Third Degree) Burn 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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