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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
EPIC MEDICAL PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
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 935 935

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2821 2821
Device Contamination with Chemical or Other Material 2020 2022
Air/Gas in Device 240 240
Contamination /Decontamination Problem 164 164
Leak/Splash 113 113
Contamination 83 83
Free or Unrestricted Flow 81 81
Material Puncture/Hole 65 65
No Flow 63 63
Detachment of Device or Device Component 52 52
Break 43 43
Disconnection 42 42
Infusion or Flow Problem 40 40
Particulates 33 33
Device Alarm System 25 25
Complete Blockage 22 22
Unsealed Device Packaging 21 21
Tear, Rip or Hole in Device Packaging 15 15
Delivered as Unsterile Product 15 15
Obstruction of Flow 14 14
Defective Component 14 14
Backflow 14 14
Insufficient Device Problem Information 13 13
Defective Device 13 13
Loose or Intermittent Connection 12 12
Illegible Information 11 11
Appropriate Device Problem Term/Code Not Available 11 11
Fitting Problem 10 10
Material Split, Cut or Torn 10 10
Crack 10 10
Component Missing 10 10
Failure to Infuse 9 9
Product Quality Problem 9 9
Labelling, Instructions for Use or Training Problem 9 9
Protective Measures Problem 9 9
Material Rupture 9 9
Device Contaminated During Manufacture or Shipping 8 8
Device Damaged Prior to Use 8 8
Precipitate in Device or Device Ingredient 7 7
Failure to Align 7 7
Therapeutic or Diagnostic Output Failure 6 6
Volume Accuracy Problem 6 6
Inadequate Filtration Process 6 6
Loss of or Failure to Bond 6 6
Naturally Worn 6 6
Component Misassembled 5 5
Increase in Pressure 5 5
Incomplete or Inadequate Connection 5 5
Audible Prompt/Feedback Problem 5 5
Inaccurate Delivery 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6490 7019
Insufficient Information 543 796
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 and Conditions Term/Code Not Available 8 22
Hot Flashes/Flushes 4 6
Swelling/ Edema 4 23
Vomiting 3 10
Hemorrhage/Blood Loss/Bleeding 3 4
Tachycardia 3 3
Anxiety 3 8
Cough 3 6
Unspecified Respiratory Problem 3 15
Arrhythmia 3 7
Abdominal Pain 3 3
Itching Sensation 2 13
Peripheral Edema 2 9
Hypoxia 2 26
Sepsis 2 2
Cardiac Arrest 2 2
Electrolyte Imbalance 2 3
Hypoglycemia 2 2
Respiratory Insufficiency 2 7
Low Blood Pressure/ Hypotension 2 3
Low Oxygen Saturation 2 5
Hypervolemia 2 3
Decreased Appetite 2 2
Syncope/Fainting 2 22
Shaking/Tremors 1 1
Unspecified Tissue Injury 1 1
Contact Dermatitis 1 2
Pneumonia 1 1
Heart Failure/Congestive Heart Failure 1 2
Discomfort 1 1
Vertigo 1 1
Erythema 1 1
Thrombosis/Thrombus 1 1
Foreign Body In Patient 1 1
Fever 1 1
Pallor 1 2

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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