Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
JIANGSU CAINA MEDICAL CO.,LTD
  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 200 200

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2543 2583
Device Contamination with Chemical or Other Material 1877 1881
Device Displays Incorrect Message 249 390
Air/Gas in Device 235 242
Infusion or Flow Problem 222 378
Leak/Splash 142 149
Protective Measures Problem 141 260
Defective Device 128 181
Contamination /Decontamination Problem 123 123
Defective Component 81 128
Free or Unrestricted Flow 80 80
Nonstandard Device 77 680
Break 76 93
Device Alarm System 74 128
Contamination 72 72
Output Problem 67 152
Material Puncture/Hole 66 66
Detachment of Device or Device Component 51 52
Therapeutic or Diagnostic Output Failure 49 80
Disconnection 42 57
No Flow 33 45
Display or Visual Feedback Problem 30 52
Obstruction of Flow 22 34
Complete Blockage 22 22
Unsealed Device Packaging 21 21
Component Missing 18 19
Improper Flow or Infusion 17 25
Backflow 16 16
Tear, Rip or Hole in Device Packaging 15 15
Pressure Problem 15 43
Crack 15 31
Use of Device Problem 15 21
Delivered as Unsterile Product 14 14
Loose or Intermittent Connection 14 14
Noise, Audible 14 35
Device Difficult to Setup or Prepare 13 18
Particulates 13 13
Connection Problem 13 14
Insufficient Flow or Under Infusion 12 42
Illegible Information 11 11
Material Twisted/Bent 11 24
Pumping Stopped 11 16
Material Rupture 10 11
Fitting Problem 10 10
Product Quality Problem 10 16
Patient Device Interaction Problem 10 13
Increase in Pressure 9 17
Inaccurate Delivery 9 24
Material Split, Cut or Torn 9 9
Insufficient Information 9 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5770 6299
Insufficient Information 529 782
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 22
Unspecified Infection 8 8
Hot Flashes/Flushes 4 6
Swelling/ Edema 4 23
Vomiting 3 10
Tachycardia 3 3
Anxiety 3 8
Cough 3 6
Unspecified Respiratory Problem 3 15
Arrhythmia 3 7
Abdominal Pain 3 3
Sepsis 2 2
Hypoxia 2 26
Itching Sensation 2 13
Hemorrhage/Bleeding 2 3
Peripheral Edema 2 9
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
Decreased Appetite 2 2
Hypervolemia 2 3
Syncope/Fainting 2 22
Unspecified Tissue Injury 1 1
Contact Dermatitis 1 2
Shaking/Tremors 1 1
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
Rash 1 12

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
-
-