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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
AVENIR PERFORMANCE EUROPEENNE MEDICAL (APEM)
  SUBSTANTIALLY EQUIVALENT 2
AVENIR PERFORMANCE EUROPÉENNE MEDICAL (APEM)
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
GCMEDICA ENTERPRISE LTD., (WUXI)
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
IPAX, INC
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS GRIFOLS, S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMOP MEDICAL PROJECT LTD.
  SUBSTANTIALLY EQUIVALENT 2
OMNICELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SFM MEDICAL DEVICES GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
WEST PHARMA SERVICES IL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEST PHARMACEUTICAL SERVICES AZ, INC.
  SUBSTANTIALLY EQUIVALENT 1
YUKON MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 533 533
2018 1497 1497
2019 1633 1789
2020 1167 1167
2021 929 929
2022 1409 1409

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 4166 4254
Device Contamination with Chemical or Other Material 1090 1152
Leak/Splash 293 293
Device Displays Incorrect Message 253 253
Infusion or Flow Problem 186 186
Break 174 174
Protective Measures Problem 130 130
Disconnection 119 124
Material Puncture/Hole 106 106
Defective Device 91 91
Contamination /Decontamination Problem 89 89
Defective Component 72 72
Device Alarm System 72 72
Free or Unrestricted Flow 60 60
Output Problem 50 50
Therapeutic or Diagnostic Output Failure 49 49
Hole In Material 45 45
Difficult to Open or Close 34 34
Material Rupture 27 27
Air/Gas in Device 26 26
Crack 25 25
Improper Flow or Infusion 24 24
No Flow 24 24
Detachment of Device or Device Component 24 24
Device Operates Differently Than Expected 20 20
Insufficient Information 19 19
Display or Visual Feedback Problem 19 19
Excess Flow or Over-Infusion 18 18
Material Perforation 18 18
Loose or Intermittent Connection 17 17
Component Missing 16 16
Failure to Align 16 16
Unsealed Device Packaging 14 16
Material Separation 13 13
Filling Problem 13 13
Connection Problem 13 13
Material Split, Cut or Torn 13 13
Device Markings/Labelling Problem 12 12
Fitting Problem 11 11
Use of Device Problem 11 11
Pumping Stopped 11 11
Complete Blockage 10 10
Tear, Rip or Hole in Device Packaging 10 10
Gas Leak 10 10
Material Deformation 9 9
Detachment Of Device Component 9 9
Material Opacification 9 9
Misassembled 9 9
Delivered as Unsterile Product 9 9
Noise, Audible 9 9
Improper or Incorrect Procedure or Method 8 8
Insufficient Flow or Under Infusion 8 8
Material Integrity Problem 8 8
Cut In Material 8 8
Pressure Problem 7 7
Volume Accuracy Problem 7 7
Mechanical Problem 7 7
Failure to Prime 7 7
Contamination 7 7
Patient Device Interaction Problem 7 7
Backflow 6 6
Material Discolored 6 6
Particulates 6 6
Packaging Problem 6 6
Material Twisted/Bent 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Obstruction of Flow 5 5
Inaccurate Delivery 5 5
Precipitate in Device or Device Ingredient 5 5
Increase in Pressure 5 5
Product Quality Problem 5 5
Inflation Problem 5 5
Priming Problem 5 5
Audible Prompt/Feedback Problem 4 4
Incomplete or Inadequate Connection 4 4
Partial Blockage 4 7
Air Leak 4 4
Defective Alarm 4 4
Structural Problem 4 4
Device Damaged Prior to Use 4 4
Appropriate Term/Code Not Available 4 4
Pumping Problem 4 4
Material Protrusion/Extrusion 4 4
Device Contaminated During Manufacture or Shipping 3 3
Scratched Material 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Failure to Deliver 3 3
Failure to Infuse 3 3
Bent 3 3
Reflux within Device 3 4
Device Difficult to Setup or Prepare 3 3
Failure to Power Up 3 3
Misconnection 3 3
Unexpected Shutdown 3 3
Device Fell 2 2
Component Misassembled 2 2
Nonstandard Device 2 2
Device Slipped 2 2
Labelling, Instructions for Use or Training Problem 2 2
Material Fragmentation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3790 3886
No Clinical Signs, Symptoms or Conditions 1699 1699
No Consequences Or Impact To Patient 599 603
No Known Impact Or Consequence To Patient 481 537
Insufficient Information 435 435
No Information 63 63
No Code Available 16 16
Headache 10 10
Pain 8 8
Hemorrhage/Bleeding 6 6
Chemical Exposure 6 6
Dyspnea 5 5
Diarrhea 4 4
Fatigue 3 3
Anxiety 3 3
Malaise 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Underdose 2 2
Premature Labor 2 2
Blood Loss 2 2
Vomiting 2 2
Dizziness 2 2
Chest Pain 2 2
Nausea 2 2
Skin Discoloration 1 1
Swelling 1 1
Tachycardia 1 1
Purulent Discharge 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Low Blood Pressure/ Hypotension 1 1
Itching Sensation 1 1
Thromboembolism 1 1
Dysuria 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Pallor 1 1
Shaking/Tremors 1 1
Discomfort 1 1
Arthralgia 1 1
Radiation Exposure, Unintended 1 1
Heart Failure/Congestive Heart Failure 1 1
Unspecified Respiratory Problem 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Decreased Appetite 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Mar-07-2022
2 Baxter Healthcare Corporation II Aug-24-2022
3 Baxter Healthcare Corporation II Oct-21-2019
4 Baxter Healthcare Corporation II May-22-2018
5 Medimop Medical Projects Ltd. II Mar-12-2018
6 WEST PHARMA. SERVICES IL, LTD I Jan-28-2019
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