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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 1

MDR Year MDR Reports MDR Events
2017 2620 2620
2018 1650 1650
2019 742 742
2020 1460 1460
2021 1218 1218
2022 246 246

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 1787 1787
No Audible Alarm 852 852
Protective Measures Problem 817 817
No Display/Image 805 805
Excess Flow or Over-Infusion 623 623
Loss of Power 576 576
Device Alarm System 249 249
Failure to Deliver 212 212
Insufficient Flow or Under Infusion 211 211
Leak/Splash 209 209
Volume Accuracy Problem 168 168
Inaccurate Flow Rate 163 163
Failure to Auto Stop 141 141
Thermal Decomposition of Device 135 135
Infusion or Flow Problem 123 123
Air/Gas in Device 123 123
Detachment of Device or Device Component 120 120
Use of Device Problem 118 118
Inaccurate Delivery 104 104
Display or Visual Feedback Problem 102 102
Device Operates Differently Than Expected 59 59
Improper Flow or Infusion 53 53
Device Displays Incorrect Message 43 43
Device Stops Intermittently 38 38
Detachment Of Device Component 38 38
Human-Device Interface Problem 36 36
Delayed Alarm 34 34
Overheating of Device 32 32
Break 30 30
Failure to Power Up 24 24
Decreased Pump Speed 24 24
Increased Pump Speed 24 24
Defective Alarm 23 23
Defective Component 15 15
Improper or Incorrect Procedure or Method 14 14
Self-Activation or Keying 14 14
Occlusion Within Device 13 13
Appropriate Term/Code Not Available 13 13
Power Problem 13 13
Disconnection 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Poor Quality Image 9 9
Defective Device 9 9
Obstruction of Flow 9 9
Incorrect Or Inadequate Test Results 9 9
Incorrect Measurement 8 8
Mechanical Problem 8 8
Fire 8 8
Melted 7 7
Unable to Obtain Readings 7 7
Material Separation 7 7
Electrical Power Problem 7 7
Battery Problem 6 6
Pumping Stopped 6 6
Material Puncture/Hole 6 6
Hole In Material 6 6
Electrical /Electronic Property Problem 6 6
Crack 6 6
Pumping Problem 6 6
Temperature Problem 5 5
Output Problem 5 5
Device Handling Problem 5 5
Noise, Audible 5 5
Use of Incorrect Control Settings 5 5
Image Display Error/Artifact 5 5
Sparking 5 5
Free or Unrestricted Flow 5 5
Failure to Shut Off 4 4
Failure of Device to Self-Test 4 4
Device Issue 4 4
Smoking 4 4
Failure to Prime 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Material Rupture 4 4
Display Difficult to Read 4 4
Insufficient Information 4 4
Output below Specifications 3 3
Erratic or Intermittent Display 3 3
Corroded 3 3
Flushing Problem 3 3
Alarm Not Visible 3 3
Complete Blockage 3 3
Power Conditioning Problem 3 3
Output above Specifications 3 3
Device Inoperable 3 3
Inaudible or Unclear Audible Prompt/Feedback 3 3
Failure to Infuse 3 3
Failure to Disconnect 3 3
Calibration Problem 3 3
Delivery System Failure 3 3
Device Dislodged or Dislocated 3 3
Electrical Shorting 2 2
Device Contamination with Chemical or Other Material 2 2
Device Operational Issue 2 2
Contamination of Device Ingredient or Reagent 2 2
Issue With Displayed Error Message 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Inadequate or Insufficient Training 2 2
Failure to Sense 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2341 2341
No Consequences Or Impact To Patient 2098 2098
No Clinical Signs, Symptoms or Conditions 1523 1523
No Known Impact Or Consequence To Patient 1369 1369
No Information 474 474
Insufficient Information 92 92
Vomiting 28 28
Dyskinesia 21 21
Not Applicable 20 20
Overdose 16 16
Nausea 14 14
Ambulation Difficulties 14 14
Discomfort 13 13
Abdominal Distention 12 12
No Code Available 10 10
Cognitive Changes 6 6
Shaking/Tremors 6 6
Muscle Spasm(s) 6 6
Feeding Problem 6 6
Hypoglycemia 5 5
Device Overstimulation of Tissue 5 5
Pain 5 5
Anxiety 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Sleep Dysfunction 4 4
Urinary Retention 4 4
Flatus 4 4
Death 4 4
Dyspnea 4 4
Abdominal Pain 3 3
Fatigue 3 3
Tachycardia 3 3
Malaise 3 3
Electric Shock 3 3
Weight Changes 3 3
Abdominal Cramps 2 2
Distress 2 2
Weakness 2 2
Twitching 2 2
Complaint, Ill-Defined 2 2
Loss of consciousness 2 2
Hyperglycemia 2 2
Visual Disturbances 2 2
Unspecified Infection 2 2
Fall 2 2
Dementia 2 2
Aspiration/Inhalation 1 1
Burn(s) 1 1
Chest Pain 1 1
Headache 1 1
Muscle Stimulation 1 1
Fever 1 1
Muscular Rigidity 1 1
Undesired Nerve Stimulation 1 1
Neurological Deficit/Dysfunction 1 1
Pneumonia 1 1
Pneumothorax 1 1
Loss of Range of Motion 1 1
Respiratory Distress 1 1
Sepsis 1 1
Swelling 1 1
Mitral Valve Prolapse 1 1
Low Oxygen Saturation 1 1
Sudden Cardiac Death 1 1
Inadequate Pain Relief 1 1
Dysphasia 1 1
Tingling 1 1
Hypernatremia 1 1
Pressure Sores 1 1
Underdose 1 1
Lethargy 1 1
Blood Loss 1 1
Confusion/ Disorientation 1 1
Patient Problem/Medical Problem 1 1
Constipation 1 1
Convulsion/Seizure 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Gastrointestinal Regurgitation 1 1
Device Embedded In Tissue or Plaque 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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