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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
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
GCMEDICA ENTERPRISE LTD., (WUXI)
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ICU MEDICAL
  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 2
SHANGHAI LING FU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
WEST PHARMA SERVICES IL, LTD.
  SUBSTANTIALLY EQUIVALENT 5
WEST PHARMACEUTICAL SERVICES AZ, INC.
  SUBSTANTIALLY EQUIVALENT 1
WEST PHARMACEUTICAL SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1633 1789
2020 1167 1167
2021 923 923
2022 1836 1836
2023 1048 1048
2024 268 268

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 3552 3640
Device Contamination with Chemical or Other Material 1189 1251
Device Displays Incorrect Message 252 252
Leak/Splash 224 224
Infusion or Flow Problem 204 204
Break 144 144
Protective Measures Problem 139 139
Defective Device 111 111
Contamination /Decontamination Problem 107 107
Material Puncture/Hole 107 107
Disconnection 90 95
Defective Component 80 80
Device Alarm System 78 78
Nonstandard Device 75 75
Free or Unrestricted Flow 73 73
Output Problem 64 64
Air/Gas in Device 63 63
Therapeutic or Diagnostic Output Failure 49 49
Detachment of Device or Device Component 39 39
Difficult to Open or Close 35 35
Improper Flow or Infusion 28 28
No Flow 27 27
Contamination 27 27
Display or Visual Feedback Problem 26 26
Loose or Intermittent Connection 24 24
Crack 21 21
Unsealed Device Packaging 21 23
Component Missing 16 16
Pressure Problem 15 15
Connection Problem 13 13
Failure to Align 13 13
Device Difficult to Setup or Prepare 13 13
Backflow 13 13
Complete Blockage 12 12
Noise, Audible 12 12
Material Twisted/Bent 12 12
Illegible Information 12 12
Material Split, Cut or Torn 11 11
Gas/Air Leak 11 11
Pumping Stopped 11 11
Use of Device Problem 11 11
Fitting Problem 11 11
Insufficient Flow or Under Infusion 10 10
Material Separation 10 10
Patient Device Interaction Problem 10 10
Obstruction of Flow 9 9
Material Rupture 9 9
Product Quality Problem 9 9
Increase in Pressure 9 9
Tear, Rip or Hole in Device Packaging 9 9
Inaccurate Delivery 8 8
Failure to Prime 8 8
Mechanical Problem 8 8
Device Markings/Labelling Problem 8 8
Material Deformation 8 8
Packaging Problem 8 8
Pumping Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 7 7
Material Discolored 7 7
Precipitate in Device or Device Ingredient 7 7
Material Perforation 7 7
Volume Accuracy Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Particulates 6 6
Delivered as Unsterile Product 6 6
Activation Failure 6 6
Incomplete or Inadequate Connection 6 6
Priming Problem 6 6
Device Contaminated During Manufacture or Shipping 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Protrusion/Extrusion 5 5
Audible Prompt/Feedback Problem 5 5
Filling Problem 5 5
Failure to Infuse 5 5
Device Slipped 4 4
Device Damaged Prior to Use 4 4
Reflux within Device 4 5
Labelling, Instructions for Use or Training Problem 4 4
Material Opacification 4 4
Misassembled 4 4
Defective Alarm 4 4
Appropriate Term/Code Not Available 4 4
Structural Problem 4 4
Difficult or Delayed Activation 4 4
Failure to Deliver 4 4
Expiration Date Error 3 3
Material Integrity Problem 3 3
Component Misassembled 3 3
Scratched Material 3 3
Device Fell 3 3
Unexpected Shutdown 3 3
False Alarm 3 3
Partial Blockage 3 6
Restricted Flow rate 3 3
Inaccurate Flow Rate 3 3
Unable to Obtain Readings 3 3
Failure to Power Up 3 3
Shipping Damage or Problem 2 2
Incomplete or Missing Packaging 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3288 3288
No Patient Involvement 2260 2356
Insufficient Information 480 480
No Consequences Or Impact To Patient 389 393
No Known Impact Or Consequence To Patient 251 307
Dyspnea 34 34
Headache 29 29
No Information 22 22
Dizziness 17 17
Pain 15 15
Fatigue 11 11
Diarrhea 11 11
Nausea 10 10
Chest Pain 8 8
Unspecified Infection 8 8
Malaise 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Chemical Exposure 5 5
Swelling/ Edema 4 4
Hot Flashes/Flushes 4 4
Vomiting 3 3
Tachycardia 3 3
Anxiety 3 3
Arrhythmia 3 3
Unspecified Respiratory Problem 3 3
Cough 3 3
Respiratory Insufficiency 2 2
Decreased Appetite 2 2
Hypervolemia 2 2
Syncope/Fainting 2 2
Electrolyte Imbalance 2 2
Premature Labor 2 2
Low Oxygen Saturation 2 2
Abdominal Pain 2 2
Purulent Discharge 2 2
Itching Sensation 2 2
Hypoglycemia 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Sepsis 2 2
Skin Discoloration 1 1
Swelling 1 1
Pneumonia 1 1
Rash 1 1
Red Eye(s) 1 1
Discomfort 1 1
Arthralgia 1 1
Vertigo 1 1
Muscle Weakness 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Erythema 1 1
Adult Respiratory Distress Syndrome 1 1
Anemia 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Shaking/Tremors 1 1
Underdose 1 1
Pallor 1 1
Diaphoresis 1 1
Taste Disorder 1 1
Thrombosis/Thrombus 1 1
Heart Failure/Congestive Heart Failure 1 1
Foreign Body In Patient 1 1
Blood Loss 1 1
Weight Changes 1 1
Pulmonary Hypertension 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 I Feb-16-2024
3 Baxter Healthcare Corporation II Aug-24-2022
4 Baxter Healthcare Corporation II Oct-21-2019
5 International Medical Industries, Inc. II Jan-07-2023
6 WEST PHARMA. SERVICES IL, LTD I Jan-28-2019
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