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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
Regulation Description Intravascular administration set.
Product CodeLHI
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVCARE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AEA SRL
  SUBSTANTIALLY EQUIVALENT 1
ASSET MEDIKAL TASARIM SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
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
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL, 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 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
YUKON MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1167 1167
2021 923 923
2022 1837 1837
2023 1048 1048
2024 1270 1270
2025 205 205

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2688 2688
Device Contamination with Chemical or Other Material 1675 1675
Device Displays Incorrect Message 249 249
Infusion or Flow Problem 199 199
Leak/Splash 175 175
Protective Measures Problem 141 141
Break 129 129
Defective Device 110 110
Material Puncture/Hole 86 86
Contamination /Decontamination Problem 82 82
Defective Component 81 81
Free or Unrestricted Flow 80 80
Air/Gas in Device 77 77
Device Alarm System 76 76
Nonstandard Device 75 75
Disconnection 73 73
Output Problem 64 64
Contamination 52 52
Therapeutic or Diagnostic Output Failure 49 49
Detachment of Device or Device Component 40 40
Difficult to Open or Close 34 34
Display or Visual Feedback Problem 26 26
Improper Flow or Infusion 25 25
No Flow 25 25
Loose or Intermittent Connection 19 19
Crack 18 18
Unsealed Device Packaging 16 16
Material Split, Cut or Torn 16 16
Backflow 15 15
Pressure Problem 15 15
Component Missing 14 14
Delivered as Unsterile Product 14 14
Device Difficult to Setup or Prepare 13 13
Tear, Rip or Hole in Device Packaging 13 13
Connection Problem 12 12
Obstruction of Flow 12 12
Noise, Audible 12 12
Material Twisted/Bent 11 11
Use of Device Problem 11 11
Pumping Stopped 11 11
Illegible Information 11 11
Complete Blockage 11 11
Fitting Problem 10 10
Patient Device Interaction Problem 10 10
Product Quality Problem 10 10
Insufficient Flow or Under Infusion 10 10
Increase in Pressure 9 9
Material Separation 9 9
Material Rupture 9 9
Precipitate in Device or Device Ingredient 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4471 4471
No Patient Involvement 1032 1032
Insufficient Information 494 494
No Consequences Or Impact To Patient 178 178
No Known Impact Or Consequence To Patient 78 78
Dyspnea 34 34
Headache 34 34
Pain 20 20
Diarrhea 19 19
Dizziness 17 17
Fatigue 12 12
Nausea 11 11
Chest Pain 9 9
Malaise 9 9
Unspecified Infection 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Hot Flashes/Flushes 4 4
No Information 4 4
Swelling/ Edema 4 4
Vomiting 3 3
Tachycardia 3 3
Anxiety 3 3
Cough 3 3
Chemical Exposure 3 3
Unspecified Respiratory Problem 3 3
Arrhythmia 3 3
Abdominal Pain 3 3
Itching Sensation 2 2
Hypoxia 2 2
Electrolyte Imbalance 2 2
Hemorrhage/Bleeding 2 2
Respiratory Insufficiency 2 2
Sepsis 2 2
Hypoglycemia 2 2
Low Blood Pressure/ Hypotension 2 2
Low Oxygen Saturation 2 2
Hypervolemia 2 2
Decreased Appetite 2 2
Discomfort 2 2
Syncope/Fainting 2 2
Unspecified Tissue Injury 1 1
Contact Dermatitis 1 1
Shaking/Tremors 1 1
Heart Failure/Congestive Heart Failure 1 1
Pneumonia 1 1
Vertigo 1 1
Erythema 1 1
Thrombosis/Thrombus 1 1
Foreign Body In Patient 1 1
Pallor 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Mar-07-2022
2 Baxter Healthcare Corporation I Sep-19-2024
3 Baxter Healthcare Corporation I Feb-16-2024
4 Baxter Healthcare Corporation II Aug-24-2022
5 International Medical Industries, Inc. II Jan-07-2023
6 West Pharmaceutical Services AZ, Inc. II Nov-01-2024
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