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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
ASSET MEDIKAL TASARIM SANAYI VE TICARET A.S.
  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
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
GCMEDICA ENTERPRISE LTD., (WUXI)
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
ICU MEDICAL
  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 3
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

MDR Year MDR Reports MDR Events
2019 1633 1789
2020 1167 1167
2021 923 923
2022 1836 1836
2023 1048 1048
2024 639 639

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 3755 3843
Device Contamination with Chemical or Other Material 1288 1350
Device Displays Incorrect Message 252 252
Leak/Splash 224 224
Infusion or Flow Problem 206 206
Break 148 148
Protective Measures Problem 142 142
Material Puncture/Hole 115 115
Contamination /Decontamination Problem 111 111
Defective Device 111 111
Disconnection 92 97
Defective Component 80 80
Device Alarm System 78 78
Nonstandard Device 75 75
Free or Unrestricted Flow 75 75
Air/Gas in Device 66 66
Output Problem 64 64
Therapeutic or Diagnostic Output Failure 49 49
Detachment of Device or Device Component 40 40
Contamination 37 37
Difficult to Open or Close 35 35
No Flow 28 28
Improper Flow or Infusion 28 28
Display or Visual Feedback Problem 26 26
Loose or Intermittent Connection 24 24
Unsealed Device Packaging 23 25
Crack 22 22
Component Missing 17 17
Pressure Problem 15 15
Complete Blockage 14 14
Backflow 14 14
Material Split, Cut or Torn 14 14
Device Difficult to Setup or Prepare 13 13
Failure to Align 13 13
Connection Problem 13 13
Material Twisted/Bent 12 12
Illegible Information 12 12
Noise, Audible 12 12
Obstruction of Flow 11 11
Material Separation 11 11
Use of Device Problem 11 11
Gas/Air Leak 11 11
Fitting Problem 11 11
Pumping Stopped 11 11
Insufficient Flow or Under Infusion 10 10
Tear, Rip or Hole in Device Packaging 10 10
Patient Device Interaction Problem 10 10
Product Quality Problem 9 9
Material Rupture 9 9
Increase in Pressure 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3649 3649
No Patient Involvement 2260 2356
Insufficient Information 488 488
No Consequences Or Impact To Patient 389 393
No Known Impact Or Consequence To Patient 251 307
Dyspnea 34 34
Headache 29 29
No Information 22 22
Dizziness 17 17
Pain 15 15
Diarrhea 12 12
Fatigue 11 11
Nausea 10 10
Unspecified Infection 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Malaise 8 8
Chest Pain 8 8
Chemical Exposure 5 5
Hot Flashes/Flushes 4 4
Swelling/ Edema 4 4
Unspecified Respiratory Problem 3 3
Cough 3 3
Anxiety 3 3
Tachycardia 3 3
Vomiting 3 3
Arrhythmia 3 3
Itching Sensation 2 2
Purulent Discharge 2 2
Decreased Appetite 2 2
Hypervolemia 2 2
Low Oxygen Saturation 2 2
Electrolyte Imbalance 2 2
Premature Labor 2 2
Low Blood Pressure/ Hypotension 2 2
Respiratory Insufficiency 2 2
Abdominal Pain 2 2
Syncope/Fainting 2 2
Hemorrhage/Bleeding 2 2
Hypoxia 2 2
Sepsis 2 2
Hypoglycemia 2 2
Weight Changes 1 1
Underdose 1 1
Pulmonary Hypertension 1 1
Unspecified Tissue Injury 1 1
Contact Dermatitis 1 1
Shaking/Tremors 1 1
Stroke/CVA 1 1
Arthralgia 1 1
Heart Failure/Congestive Heart Failure 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 Baxter Healthcare Corporation II Oct-21-2019
6 International Medical Industries, Inc. II Jan-07-2023
7 WEST PHARMA. SERVICES IL, LTD I Jan-28-2019
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