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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
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 1834 1834

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4077 4165
Device Contamination with Chemical or Other Material 983 1045
Leak/Splash 289 289
Device Displays Incorrect Message 252 252
Infusion or Flow Problem 211 211
Break 165 165
Protective Measures Problem 134 134
Material Puncture/Hole 107 107
Defective Device 98 98
Disconnection 98 103
Contamination /Decontamination Problem 92 92
Device Alarm System 79 79
Defective Component 75 75
Free or Unrestricted Flow 67 67
Nonstandard Device 60 60
Output Problem 60 60
Therapeutic or Diagnostic Output Failure 49 49
Difficult to Open or Close 34 34
Air/Gas in Device 31 31
Improper Flow or Infusion 26 26
No Flow 24 24
Detachment of Device or Device Component 24 24
Display or Visual Feedback Problem 24 24
Crack 23 23
Component Missing 20 20
Unsealed Device Packaging 19 21
Excess Flow or Over-Infusion 18 18
Material Perforation 18 18
Insufficient Information 18 18
Loose or Intermittent Connection 18 18
Failure to Align 16 16
Hole In Material 14 14
Filling Problem 13 13
Material Split, Cut or Torn 13 13
Material Rupture 13 13
Noise, Audible 12 12
Pumping Stopped 11 11
Fitting Problem 11 11
Contamination 11 11
Material Deformation 10 10
Tear, Rip or Hole in Device Packaging 10 10
Complete Blockage 10 10
Gas/Air Leak 10 10
Device Operates Differently Than Expected 10 10
Use of Device Problem 10 10
Insufficient Flow or Under Infusion 10 10
Connection Problem 10 10
Device Markings/Labelling Problem 10 10
Material Twisted/Bent 9 9
Patient Device Interaction Problem 9 9
Material Opacification 9 9
Pressure Problem 9 9
Product Quality Problem 8 8
Material Separation 8 8
Misassembled 8 8
Volume Accuracy Problem 7 7
Backflow 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Particulates 7 7
Device Difficult to Setup or Prepare 7 7
Mechanical Problem 7 7
Pumping Problem 7 7
Failure to Prime 7 7
Material Integrity Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Precipitate in Device or Device Ingredient 6 6
Obstruction of Flow 6 6
Cut In Material 6 6
Priming Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Delivered as Unsterile Product 6 6
Increase in Pressure 5 5
Structural Problem 5 5
Inaccurate Delivery 5 5
Appropriate Term/Code Not Available 5 5
Packaging Problem 5 5
Material Protrusion/Extrusion 5 5
Material Discolored 5 5
Incomplete or Inadequate Connection 5 5
Partial Blockage 4 7
Device Contaminated During Manufacture or Shipping 4 4
Failure to Infuse 4 4
Inflation Problem 4 4
Failure to Deliver 4 4
Device Slipped 4 4
Defective Alarm 4 4
Difficult or Delayed Activation 4 4
Audible Prompt/Feedback Problem 4 4
Scratched Material 3 3
Unable to Obtain Readings 3 3
Device Damaged Prior to Use 3 3
Labelling, Instructions for Use or Training Problem 3 3
Failure to Power Up 3 3
Unexpected Shutdown 3 3
Device Fell 3 3
False Alarm 3 3
Inaccurate Flow Rate 3 3
Reflux within Device 3 4
Misconnection 2 2
Detachment Of Device Component 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3374 3470
No Clinical Signs, Symptoms or Conditions 2063 2063
No Consequences Or Impact To Patient 561 565
Insufficient Information 439 439
No Known Impact Or Consequence To Patient 414 470
No Information 55 55
Dyspnea 29 29
Headache 21 21
No Code Available 16 16
Pain 13 13
Dizziness 10 10
Diarrhea 8 8
Chest Pain 7 7
Fatigue 7 7
Nausea 7 7
Hemorrhage/Bleeding 6 6
Malaise 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Chemical Exposure 5 5
Arrhythmia 3 3
Vomiting 3 3
Anxiety 3 3
Premature Labor 2 2
Tachycardia 2 2
Itching Sensation 2 2
Underdose 2 2
Hot Flashes/Flushes 2 2
Swelling/ Edema 2 2
Low Oxygen Saturation 2 2
Diaphoresis 1 1
Pallor 1 1
Low Blood Pressure/ Hypotension 1 1
Swelling 1 1
Peripheral Edema 1 1
Thromboembolism 1 1
Patient Problem/Medical Problem 1 1
Syncope/Fainting 1 1
Respiratory Insufficiency 1 1
Gastroesophageal Burn 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Arthralgia 1 1
Red Eye(s) 1 1
Abdominal Pain 1 1
Hypoxia 1 1
Muscle Weakness 1 1
Rash 1 1
Skin Discoloration 1 1
Heart Failure/Congestive Heart Failure 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Unspecified Gastrointestinal Problem 1 1
Contact Dermatitis 1 1
Purulent Discharge 1 1
Adult Respiratory Distress Syndrome 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Shaking/Tremors 1 1
Blood Loss 1 1
Hypervolemia 1 1
Decreased Appetite 1 1
Discomfort 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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