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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
2026 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Protective Measures Problem 1311 1311
Fluid/Blood Leak 409 409
Excess Flow or Over-Infusion 234 244
Air/Gas in Device 232 233
Failure to Deliver 220 220
Insufficient Flow or Under Infusion 71 71
Infusion or Flow Problem 58 58
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 10 10
Insufficient Information 9 9
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 2550 2555
Insufficient Information 106 111
Vomiting 27 28
Hypoglycemia 14 14
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
Dehydration 7 7
Abdominal Pain 6 7
No Information 5 5
Weight Changes 5 5
Aspiration/Inhalation 3 3
Flatus 3 3
Abdominal Cramps 2 2
Malaise 2 2
Unspecified Gastrointestinal Problem 2 2
Muscle Spasm(s) 2 2
Pain 2 2
Dyspnea 2 2
Hyperglycemia 2 2
Sleep Dysfunction 2 3
Lethargy 2 2
Ambulation Difficulties 2 2
Dyskinesia 1 1
Overdose 1 1
Device Overstimulation of Tissue 1 1
Confusion/ Disorientation 1 1
Electrolyte Imbalance 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Fever 1 1
Hyponatremia 1 1
Epilepsy 1 1
Fall 1 1
Arrhythmia 1 1
Choking 1 1
Hypernatremia 1 1
Gastrointestinal Regurgitation 1 1
Death 1 1
Pneumonia 1 1
Anxiety 1 1
Shaking/Tremors 1 1
Unspecified Respiratory Problem 1 1
Constipation 1 1
Dementia 1 1
Full thickness (Third Degree) Burn 1 1
Respiratory Failure 1 1

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