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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
ACACIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSINO INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDINAL HEALTH LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
VESCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZEVEX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 116 116
2015 83 83
2016 1248 1248
2017 2620 2620
2018 1651 1651
2019 742 742
2020 1460 1460
2021 1218 1218
2022 526 526
2023 284 284
2024 126 126

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1843 1843
Protective Measures Problem 1273 1273
No Audible Alarm 961 961
No Display/Image 831 831
Excess Flow or Over-Infusion 740 740
Loss of Power 671 671
Device Alarm System 364 364
Failure to Deliver 335 335
Insufficient Flow or Under Infusion 323 323
Leak/Splash 237 237
Air/Gas in Device 219 219
Device Operates Differently Than Expected 208 208
Inaccurate Delivery 195 195
Inaccurate Flow Rate 185 185
Failure to Auto Stop 183 183
Thermal Decomposition of Device 178 178
Volume Accuracy Problem 178 178
Infusion or Flow Problem 166 166
Detachment of Device or Device Component 125 125
Use of Device Problem 122 122
Display or Visual Feedback Problem 113 113
Device Displays Incorrect Message 100 100
Mechanical Problem 88 88
Break 84 84
Device Stops Intermittently 79 79
Detachment Of Device Component 76 76
Improper Flow or Infusion 76 76
Failure to Power Up 58 58
Defective Alarm 57 57
Overheating of Device 40 40
Occlusion Within Device 39 39
Disconnection 39 39
Human-Device Interface Problem 36 36
Delayed Alarm 34 34
Pumping Problem 31 31
Increased Pump Speed 29 29
Self-Activation or Keying 27 27
Decreased Pump Speed 25 25
Defective Component 21 21
Connection Problem 20 20
Power Problem 18 18
Pumping Stopped 18 18
Improper or Incorrect Procedure or Method 18 18
Defective Device 17 17
Failure to Charge 17 17
Melted 17 17
No Flow 16 16
Adverse Event Without Identified Device or Use Problem 15 15
Battery Problem 15 15
Fire 15 15
Smoking 15 15
Device Inoperable 14 14
Material Separation 13 13
Appropriate Term/Code Not Available 13 13
Improper Device Output 12 12
Free or Unrestricted Flow 12 12
Device Slipped 12 12
Sparking 12 12
Air Leak 12 12
Complete Blockage 12 12
Premature Discharge of Battery 11 11
Poor Quality Image 11 11
Incorrect Or Inadequate Test Results 11 11
Obstruction of Flow 11 11
Power Conditioning Problem 11 11
Failure to Prime 11 11
Noise, Audible 11 11
Hole In Material 10 10
Loose or Intermittent Connection 9 9
Incorrect Measurement 9 9
Failure to Infuse 9 9
Electrical Power Problem 9 9
Programming Issue 9 9
Insufficient Information 9 9
Output Problem 9 9
Device Dislodged or Dislocated 8 8
Material Rupture 8 8
Device Emits Odor 8 8
Electrical /Electronic Property Problem 8 8
Image Display Error/Artifact 7 7
Crack 7 7
Unable to Obtain Readings 7 7
Mechanics Altered 7 7
Temperature Problem 6 6
Fail-Safe Problem 6 6
Material Puncture/Hole 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Failure to Pump 6 6
Use of Incorrect Control/Treatment Settings 6 6
Display Difficult to Read 6 6
No Device Output 6 6
Kinked 6 6
Alarm Not Visible 5 5
Difficult to Remove 5 5
Sticking 5 5
Device Issue 5 5
Component Missing 5 5
Failure of Device to Self-Test 5 5
Failure to Shut Off 5 5
Device Handling Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2542 2542
No Known Impact Or Consequence To Patient 2360 2360
No Clinical Signs, Symptoms or Conditions 2185 2185
No Consequences Or Impact To Patient 2176 2176
No Information 548 548
Insufficient Information 101 101
Vomiting 47 47
No Code Available 45 45
Hypoglycemia 25 26
Dyskinesia 22 22
Overdose 21 21
Not Applicable 21 21
Feeding Problem 18 18
Nausea 16 16
Abdominal Distention 16 16
Discomfort 14 14
Ambulation Difficulties 14 14
Death 12 12
Abdominal Pain 7 7
Pain 7 7
Weight Changes 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Muscle Spasm(s) 6 6
Flatus 6 6
Cognitive Changes 6 6
Shaking/Tremors 6 6
Underdose 5 5
Anxiety 5 5
Dyspnea 5 5
Device Overstimulation of Tissue 5 5
Missed Dose 5 5
Aspiration/Inhalation 4 4
Urinary Retention 4 4
Sleep Dysfunction 4 4
Electric Shock 4 4
Complaint, Ill-Defined 3 3
Malaise 3 3
Burn(s) 3 3
Fatigue 3 3
Hyperglycemia 3 4
Pneumonia 3 3
Unspecified Infection 3 3
Tachycardia 3 3
Patient Problem/Medical Problem 2 2
Pneumothorax 2 2
Fever 2 2
Fall 2 2
Dehydration 2 2
Dementia 2 2
Loss of consciousness 2 2
Lethargy 2 2
Abdominal Cramps 2 2
Visual Disturbances 2 2
Distress 2 2
Weakness 2 2
Tingling 2 2
Twitching 2 2
Respiratory Distress 2 2
Seizures 2 2
Sepsis 1 1
Shock 1 1
Swelling 1 1
Dizziness 1 1
Dysphasia 1 1
Electrolyte Imbalance 1 1
Brain Injury 1 1
Hypernatremia 1 1
Urinary Frequency 1 1
Pressure Sores 1 1
Confusion/ Disorientation 1 1
Choking 1 1
Mitral Valve Prolapse 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 1 1
Inadequate Pain Relief 1 1
Coma 1 1
Embolism 1 1
Chest Pain 1 1
Air Embolism 1 1
Arrhythmia 1 1
Muscle Stimulation 1 1
Headache 1 1
Loss of Range of Motion 1 1
Muscular Rigidity 1 1
Inflammation 1 1
Irritation 1 1
Hypothermia 1 1
Undesired Nerve Stimulation 1 1
Neurological Deficit/Dysfunction 1 1
Internal Organ Perforation 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1
Blood Loss 1 1
Cancer 1 1
Constipation 1 1
Convulsion/Seizure 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Gastrointestinal Regurgitation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Nutrition, Abbott Laboratories II Sep-21-2009
2 CORPAK MedSystems II Oct-25-2011
3 Cardinal Health 200, LLC II Apr-02-2021
4 Cardinal Health 200, LLC II Nov-13-2020
5 Cardinal Health Inc. II May-22-2020
6 MOOG Medical Devices Group II Jan-31-2013
7 MOOG Medical Devices Group II Nov-15-2012
8 Medtronic II May-10-2016
9 Zevex International, Inc. II Sep-21-2009
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