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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, i.v. fluid transfer
Product CodeLHI
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVCARE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AEA SRL
  SUBSTANTIALLY EQUIVALENT 1
AVENIR PERFORMANCE EUROPEENNE MEDICAL (APEM)
  SUBSTANTIALLY EQUIVALENT 2
AVENIR PERFORMANCE EUROPÉENNE MEDICAL (APEM)
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
GCMEDICA ENTERPRISE LTD., (WUXI)
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
IPAX, INC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OMNICELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SFM MEDICAL DEVICES GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
WEST PHARMA SERVICES IL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEST PHARMACEUTICAL SERVICES AZ, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1497 1497
2019 1633 1789
2020 1167 1167
2021 929 929
2022 1842 1842
2023 174 174

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4150 4238
Device Contamination with Chemical or Other Material 1040 1102
Leak/Splash 289 289
Device Displays Incorrect Message 253 253
Infusion or Flow Problem 217 217
Break 167 167
Protective Measures Problem 136 136
Material Puncture/Hole 107 107
Defective Device 99 99
Disconnection 98 103
Contamination /Decontamination Problem 97 97
Device Alarm System 81 81
Defective Component 78 78
Nonstandard Device 75 75
Free or Unrestricted Flow 67 67
Output Problem 61 61
Therapeutic or Diagnostic Output Failure 49 49
Difficult to Open or Close 34 34
Air/Gas in Device 34 34
Detachment of Device or Device Component 32 32
Improper Flow or Infusion 29 29
No Flow 24 24
Crack 24 24
Display or Visual Feedback Problem 24 24
Unsealed Device Packaging 21 23
Component Missing 20 20
Material Perforation 18 18
Insufficient Information 18 18
Loose or Intermittent Connection 18 18
Excess Flow or Over-Infusion 18 18
Failure to Align 16 16
Material Split, Cut or Torn 14 14
Hole In Material 14 14
Filling Problem 13 13
Contamination 13 13
Material Rupture 13 13
Noise, Audible 13 13
Material Twisted/Bent 13 13
Insufficient Flow or Under Infusion 12 12
Fitting Problem 11 11
Pumping Stopped 11 11
Complete Blockage 11 11
Device Markings/Labelling Problem 11 11
Pressure Problem 11 11
Device Operates Differently Than Expected 10 10
Connection Problem 10 10
Tear, Rip or Hole in Device Packaging 10 10
Material Deformation 10 10
Gas/Air Leak 10 10
Patient Device Interaction Problem 10 10
Use of Device Problem 10 10
Material Separation 10 10
Material Opacification 9 9
Misassembled 8 8
Failure to Prime 8 8
Product Quality Problem 8 8
Obstruction of Flow 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Pumping Problem 7 7
Material Integrity Problem 7 7
Volume Accuracy Problem 7 7
Particulates 7 7
Device Difficult to Setup or Prepare 7 7
Increase in Pressure 7 7
Mechanical Problem 7 7
Backflow 7 7
Material Discolored 7 7
Delivered as Unsterile Product 6 6
Precipitate in Device or Device Ingredient 6 6
Improper or Incorrect Procedure or Method 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Cut In Material 6 6
Inaccurate Delivery 6 6
Priming Problem 6 6
Incomplete or Inadequate Connection 5 5
Failure to Infuse 5 5
Structural Problem 5 5
Material Protrusion/Extrusion 5 5
Packaging Problem 5 5
Appropriate Term/Code Not Available 5 5
Reflux within Device 5 6
Device Slipped 4 4
Partial Blockage 4 7
Defective Alarm 4 4
Inflation Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Failure to Deliver 4 4
Difficult or Delayed Activation 4 4
Audible Prompt/Feedback Problem 4 4
Device Damaged Prior to Use 3 3
Activation Failure 3 3
Device Fell 3 3
Unexpected Shutdown 3 3
Scratched Material 3 3
Inaccurate Flow Rate 3 3
False Alarm 3 3
Unable to Obtain Readings 3 3
Failure to Power Up 3 3
Labelling, Instructions for Use or Training Problem 3 3
Misconnection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3374 3470
No Clinical Signs, Symptoms or Conditions 2224 2224
No Consequences Or Impact To Patient 561 565
Insufficient Information 441 441
No Known Impact Or Consequence To Patient 414 470
No Information 55 55
Dyspnea 32 32
Headache 25 25
No Code Available 16 16
Pain 14 14
Dizziness 14 14
Fatigue 9 9
Chest Pain 9 9
Diarrhea 9 9
Malaise 8 8
Nausea 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Hemorrhage/Bleeding 6 6
Chemical Exposure 5 5
Hot Flashes/Flushes 4 4
Vomiting 3 3
Anxiety 3 3
Arrhythmia 3 3
Swelling/ Edema 3 3
Underdose 2 2
Decreased Appetite 2 2
Respiratory Insufficiency 2 2
Unspecified Respiratory Problem 2 2
Low Oxygen Saturation 2 2
Syncope/Fainting 2 2
Abdominal Pain 2 2
Hypoglycemia 2 2
Premature Labor 2 2
Electrolyte Imbalance 2 2
Tachycardia 2 2
Hypoxia 2 2
Itching Sensation 2 2
Muscle Weakness 1 1
Pallor 1 1
Diaphoresis 1 1
Discomfort 1 1
Arthralgia 1 1
Low Blood Pressure/ Hypotension 1 1
Rash 1 1
Red Eye(s) 1 1
Skin Discoloration 1 1
Swelling 1 1
Adult Respiratory Distress Syndrome 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Purulent Discharge 1 1
Fever 1 1
Taste Disorder 1 1
Heart Failure/Congestive Heart Failure 1 1
Cough 1 1
Pulmonary Hypertension 1 1
Shaking/Tremors 1 1
Blood Loss 1 1
Thromboembolism 1 1
Hypervolemia 1 1
Patient Problem/Medical Problem 1 1
Gastroesophageal Burn 1 1
Unspecified Gastrointestinal Problem 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Peripheral Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Mar-07-2022
2 Baxter Healthcare Corporation II Aug-24-2022
3 Baxter Healthcare Corporation II Oct-21-2019
4 Baxter Healthcare Corporation II May-22-2018
5 International Medical Industries, Inc. II Jan-07-2023
6 Medimop Medical Projects Ltd. II Mar-12-2018
7 WEST PHARMA. SERVICES IL, LTD I Jan-28-2019
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