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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
LUMINOAH
  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 116 116

Device Problems MDRs with this Device Problem Events in those MDRs
Protective Measures Problem 1344 1344
Fluid/Blood Leak 409 409
Failure to Deliver 239 239
Excess Flow or Over-Infusion 236 246
Air/Gas in Device 236 237
Insufficient Flow or Under Infusion 76 76
Infusion or Flow Problem 63 63
Inaccurate Flow Rate 30 30
Use of Device Problem 29 29
Inaccurate Delivery 25 25
Detachment of Device or Device Component 22 22
Failure to Auto Stop 21 21
Break 16 16
Defective Device 13 14
Mechanical Problem 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Insufficient Information 10 10
Improper Flow or Infusion 7 7
Fire 6 6
Disconnection 5 5
Leak/Splash 5 5
Appropriate Term/Code Not Available 5 5
Obstruction of Flow 5 5
Battery Problem 5 5
Failure to Prime 4 4
Device Alarm System 4 4
Failure to Power Up 4 4
Free or Unrestricted Flow 3 3
Material Rupture 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Displays Incorrect Message 3 3
Output Problem 3 3
Priming Problem 2 2
No Audible Alarm 2 2
Display or Visual Feedback Problem 2 2
No Flow 2 2
Pumping Problem 2 2
Charging Problem 2 2
Power Problem 2 2
Device Slipped 2 2
Nonstandard Device 1 1
Intermittent Continuity 1 1
Connection Problem 1 1
Failure to Infuse 1 1
Computer Software Problem 1 1
Defective Alarm 1 1
Complete Loss of Power 1 1
Difficult to Open or Close 1 1
Electrical /Electronic Property Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2620 2625
Insufficient Information 108 113
Vomiting 28 29
Hypoglycemia 15 15
Feeding Problem 12 12
Discomfort 11 11
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
Weight Changes 5 5
No Information 5 5
Hypernatremia 4 4
Aspiration/Inhalation 3 3
Flatus 3 3
Lethargy 2 2
Ambulation Difficulties 2 2
Choking 2 2
Pain 2 2
Hyperglycemia 2 2
Dyspnea 2 2
Muscle Spasm(s) 2 2
Electrolyte Imbalance 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
Device Overstimulation of Tissue 1 1
Overdose 1 1
Dyskinesia 1 1
Fall 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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