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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
  SUBSTANTIALLY EQUIVALENT 1
ASSET MEDIKAL TASARIM SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
AVENIR PERFORMANCE EUROPÉENNE MEDICAL (APEM)
  SUBSTANTIALLY EQUIVALENT 1
CARE FUSION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IPAX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MICROTEK MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
OMNICELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SFM MEDICAL DEVICES GMBH
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI LINGFU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
TAKEDA PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 1
WEST PHARMA. SERVICES IL, LTD.
  SUBSTANTIALLY EQUIVALENT 5
WEST PHARMACEUTICAL SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
YUKON MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 933 1033
2022 1834 3005
2023 1047 1105
2024 1270 1270
2025 1356 1356
2026 624 624

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2758 2798
Device Contamination with Chemical or Other Material 1977 1981
Air/Gas in Device 255 262
Device Displays Incorrect Message 249 390
Infusion or Flow Problem 228 384
Leak/Splash 150 157
Protective Measures Problem 143 262
Contamination /Decontamination Problem 140 140
Defective Device 128 181
Defective Component 81 128
Free or Unrestricted Flow 81 81
Break 78 95
Nonstandard Device 77 680
Contamination 76 76
Device Alarm System 74 128
Material Puncture/Hole 68 68
Output Problem 67 152
No Flow 53 65
Detachment of Device or Device Component 53 54
Therapeutic or Diagnostic Output Failure 49 80
Disconnection 43 58
Display or Visual Feedback Problem 30 52
Particulates 28 28
Obstruction of Flow 25 37
Complete Blockage 23 23
Unsealed Device Packaging 22 22
Component Missing 19 20
Improper Flow or Infusion 17 25
Product Quality Problem 17 23
Backflow 16 16
Tear, Rip or Hole in Device Packaging 16 16
Use of Device Problem 15 21
Crack 15 31
Loose or Intermittent Connection 15 15
Pressure Problem 15 43
Delivered as Unsterile Product 14 14
Connection Problem 14 15
Noise, Audible 14 35
Material Twisted/Bent 13 26
Device Difficult to Setup or Prepare 13 18
Insufficient Flow or Under Infusion 12 42
Failure to Infuse 12 17
Illegible Information 11 11
Pumping Stopped 11 16
Fitting Problem 11 11
Material Rupture 10 11
Material Split, Cut or Torn 10 10
Patient Device Interaction Problem 10 13
Insufficient Information 9 16
Increase in Pressure 9 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6183 6712
Insufficient Information 540 793
No Patient Involvement 116 116
Dyspnea 37 312
Headache 34 104
No Consequences Or Impact To Patient 25 25
Pain 21 47
Diarrhea 19 50
Dizziness 18 67
Fatigue 13 52
Nausea 12 68
Malaise 10 73
Chest Pain 9 21
Unspecified Infection 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 22
Hot Flashes/Flushes 4 6
Swelling/ Edema 4 23
Abdominal Pain 3 3
Arrhythmia 3 7
Unspecified Respiratory Problem 3 15
Cough 3 6
Anxiety 3 8
Tachycardia 3 3
Vomiting 3 10
Decreased Appetite 2 2
Hypervolemia 2 3
Low Oxygen Saturation 2 5
Low Blood Pressure/ Hypotension 2 3
Respiratory Insufficiency 2 7
Hemorrhage/Bleeding 2 3
Hypoxia 2 26
Hypoglycemia 2 2
Electrolyte Imbalance 2 3
Cardiac Arrest 2 2
Peripheral Edema 2 9
Itching Sensation 2 13
Sepsis 2 2
Syncope/Fainting 2 22
Skin Discoloration 1 2
Rash 1 12
Pallor 1 2
Fever 1 1
Foreign Body In Patient 1 1
Thrombosis/Thrombus 1 1
Chemical Exposure 1 1
Purulent Discharge 1 1
Anemia 1 1
Erythema 1 1
Vertigo 1 1
Discomfort 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 Omnicell, Inc. II Apr-04-2025
7 West Pharmaceutical Services AZ, Inc. II Nov-01-2024
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