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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
Regulation Description Infusion pump.
Product CodeLZH
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
VESCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1218 1224
2022 526 531
2023 284 284
2024 319 319
2025 378 378

Device Problems MDRs with this Device Problem Events in those MDRs
Protective Measures Problem 1291 1291
Fluid/Blood Leak 409 409
Excess Flow or Over-Infusion 232 242
Air/Gas in Device 229 230
Failure to Deliver 216 216
Insufficient Flow or Under Infusion 68 68
Infusion or Flow Problem 57 57
Inaccurate Flow Rate 30 30
Use of Device Problem 28 28
Inaccurate Delivery 24 24
Detachment of Device or Device Component 21 21
Failure to Auto Stop 21 21
Defective Device 13 14
Break 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Mechanical Problem 9 9
Insufficient Information 8 8
Improper Flow or Infusion 7 7
Fire 6 6
Appropriate Term/Code Not Available 5 5
Obstruction of Flow 5 5
Battery Problem 5 5
Disconnection 5 5
Leak/Splash 5 5
Failure to Power Up 4 4
Failure to Prime 4 4
Therapeutic or Diagnostic Output Failure 3 3
Device Displays Incorrect Message 3 3
Device Alarm System 3 3
Output Problem 3 3
Material Rupture 3 3
No Audible Alarm 2 2
No Flow 2 2
Display or Visual Feedback Problem 2 2
Pumping Problem 2 2
Priming Problem 2 2
Charging Problem 2 2
Device Slipped 2 2
Power Problem 2 2
Free or Unrestricted Flow 2 2
Noise, Audible 1 1
Temperature Problem 1 1
Failure to Run on Battery 1 1
Improper or Incorrect Procedure or Method 1 1
Electrical /Electronic Property Problem 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Failure to Infuse 1 1
Computer Software Problem 1 1
Defective Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2517 2522
Insufficient Information 106 111
Vomiting 27 28
Hypoglycemia 13 13
Discomfort 11 11
Feeding Problem 10 10
No Consequences Or Impact To Patient 9 9
Abdominal Distention 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Nausea 8 8
Abdominal Pain 6 7
Dehydration 6 6
Weight Changes 5 5
No Information 5 5
Aspiration/Inhalation 3 3
Flatus 3 3
Lethargy 2 2
Ambulation Difficulties 2 2
Pain 2 2
Hyperglycemia 2 2
Dyspnea 2 2
Muscle Spasm(s) 2 2
Abdominal Cramps 2 2
Malaise 2 2
Unspecified Gastrointestinal Problem 2 2
Sleep Dysfunction 2 3
Unspecified Mental, Emotional or Behavioural Problem 1 1
Fever 1 1
Confusion/ Disorientation 1 1
Electrolyte Imbalance 1 1
Device Overstimulation of Tissue 1 1
Overdose 1 1
Dyskinesia 1 1
Fall 1 1
Hypernatremia 1 1
Choking 1 1
Hyponatremia 1 1
Pneumonia 1 1
Gastrointestinal Regurgitation 1 1
Anxiety 1 1
Shaking/Tremors 1 1
Epilepsy 1 1
Unspecified Respiratory Problem 1 1
Death 1 1
Constipation 1 1
Dementia 1 1
Respiratory Failure 1 1
Full thickness (Third Degree) Burn 1 1
Arrhythmia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Apr-02-2021
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