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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 3
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BD MEDICAL-MEDICAL SURGICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
CARMEL PHARMA AB.
  SUBSTANTIALLY EQUIVALENT 3
DUOJECT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EQUASHIELD MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
GCMEDICA ENTERPRISE LTD., (WUXI)
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
INVIRO MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IPAX, INC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KIRO ROBOTICS S.L.
  SUBSTANTIALLY EQUIVALENT 1
LABORATORIOS GRIFOLS, S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDIMOP MEDICAL PROJECT LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDIMOP MEDICAL PROJECTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMOP MEDICAL PROJECTS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDSOURCE INTERNATIONAL, LLC.
  SUBSTANTIALLY EQUIVALENT 3
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OMNICELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHARMC, LLC
  SUBSTANTIALLY EQUIVALENT 1
PLASTMED, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SFM MEDICAL DEVICES GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI JINTA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
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
YUKON MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
YUKON MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 155 155
2015 126 126
2016 219 219
2017 533 533
2018 1497 1497
2019 1633 1789
2020 1167 1167
2021 923 923
2022 1836 1836
2023 1048 1048
2024 208 208

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 5045 5133
Device Contamination with Chemical or Other Material 1637 1699
Leak/Splash 381 381
Device Displays Incorrect Message 256 256
Infusion or Flow Problem 221 221
Break 202 202
Protective Measures Problem 139 139
Disconnection 136 141
Material Puncture/Hole 124 124
Defective Device 119 119
Contamination /Decontamination Problem 117 117
Defective Component 84 84
Device Alarm System 81 81
Nonstandard Device 76 76
Device Operates Differently Than Expected 74 74
Free or Unrestricted Flow 74 74
Output Problem 64 64
Air/Gas in Device 63 63
Hole In Material 53 53
Detachment of Device or Device Component 50 50
Therapeutic or Diagnostic Output Failure 49 49
Difficult to Open or Close 36 36
Improper Flow or Infusion 35 35
No Flow 35 35
Insufficient Information 33 33
Material Rupture 31 31
Crack 31 31
Connection Problem 30 30
Contamination 28 28
Loose or Intermittent Connection 28 28
Display or Visual Feedback Problem 26 26
Tear, Rip or Hole in Device Packaging 26 26
Component Missing 22 22
Unsealed Device Packaging 22 24
Chemical Spillage 21 21
Detachment Of Device Component 20 20
Material Separation 19 19
Material Perforation 18 18
Failure to Align 18 18
Excess Flow or Over-Infusion 18 18
Pressure Problem 16 16
Material Split, Cut or Torn 15 15
Product Quality Problem 15 15
Fitting Problem 15 15
Device Markings/Labelling Problem 14 14
Particulates 14 14
Delivered as Unsterile Product 14 14
Filling Problem 14 14
Device Difficult to Setup or Prepare 13 13
Material Twisted/Bent 13 13
Material Deformation 13 13
Use of Device Problem 13 13
Noise, Audible 13 13
Illegible Information 12 12
Backflow 12 12
Complete Blockage 11 11
Failure to Prime 11 11
Pumping Stopped 11 11
Insufficient Flow or Under Infusion 11 11
Material Integrity Problem 11 11
Gas/Air Leak 11 11
Increase in Pressure 10 10
Patient Device Interaction Problem 10 10
Packaging Problem 10 10
Material Opacification 9 9
Mechanical Problem 9 9
Misassembled 9 9
Material Discolored 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Device Packaging Compromised 9 9
Improper or Incorrect Procedure or Method 9 9
Inaccurate Delivery 9 9
Obstruction of Flow 8 8
Cut In Material 8 8
Device Contaminated During Manufacture or Shipping 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Device Damaged Prior to Use 7 7
Volume Accuracy Problem 7 7
Precipitate in Device or Device Ingredient 7 7
Pumping Problem 7 7
Activation Failure 6 6
Incomplete or Inadequate Connection 6 6
Priming Problem 6 6
Device Slipped 6 6
Failure to Infuse 6 6
Material Protrusion/Extrusion 6 6
Device Dislodged or Dislocated 5 5
Structural Problem 5 5
Reflux within Device 5 6
Inflation Problem 5 5
Air Leak 5 5
Audible Prompt/Feedback Problem 5 5
Appropriate Term/Code Not Available 5 5
Scratched Material 4 4
Defective Alarm 4 4
Partial Blockage 4 7
Component Falling 4 4
Labelling, Instructions for Use or Training Problem 4 4
Misconnection 4 4
Failure to Deliver 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 4074 4170
No Clinical Signs, Symptoms or Conditions 3229 3229
No Consequences Or Impact To Patient 629 633
No Known Impact Or Consequence To Patient 619 675
Insufficient Information 480 480
No Information 80 80
Dyspnea 33 33
Headache 28 28
Chemical Exposure 23 23
No Code Available 19 19
Dizziness 16 16
Pain 16 16
Fatigue 11 11
Diarrhea 11 11
Nausea 10 10
Unspecified Infection 9 9
Fever 9 9
Chest Pain 8 8
Malaise 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Hemorrhage/Bleeding 7 7
Hot Flashes/Flushes 4 4
Swelling/ Edema 4 4
Underdose 3 3
Unspecified Respiratory Problem 3 3
Vomiting 3 3
Tachycardia 3 3
Anxiety 3 3
Cough 3 3
Blood Loss 3 3
Arrhythmia 3 3
Exposure to Body Fluids 2 2
Abdominal Pain 2 2
Purulent Discharge 2 2
Hypoglycemia 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Eye Injury 2 2
Sepsis 2 2
Hypervolemia 2 2
Foreign Body In Patient 2 2
Syncope/Fainting 2 2
Electrolyte Imbalance 2 2
Needle Stick/Puncture 2 2
Premature Labor 2 2
Low Oxygen Saturation 2 2
Respiratory Insufficiency 2 2
Decreased Appetite 2 2
Peripheral Edema 1 1
Gastroesophageal Burn 1 1
Unspecified Gastrointestinal Problem 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Shaking/Tremors 1 1
Pallor 1 1
Diaphoresis 1 1
Discomfort 1 1
Injury 1 1
Arthralgia 1 1
Vertigo 1 1
Taste Disorder 1 1
Heart Failure/Congestive Heart Failure 1 1
Pulmonary Hypertension 1 1
Radiation Exposure, Unintended 1 1
Patient Problem/Medical Problem 1 1
Dysuria 1 1
Weight Changes 1 1
Thromboembolism 1 1
Skin Discoloration 1 1
Swelling 1 1
Pneumonia 1 1
Rash 1 1
Red Eye(s) 1 1
Muscle Weakness 1 1
Hypersensitivity/Allergic reaction 1 1
Corneal Abrasion 1 1
Erythema 1 1
Adult Respiratory Distress Syndrome 1 1
Anaphylactic Shock 1 1
Anemia 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical Inc I Nov-05-2010
2 B. Braun Medical, Inc. II Mar-07-2022
3 B. Braun Medical, Inc. II Jun-02-2016
4 B. Braun Medical, Inc. II Nov-27-2013
5 Baxa Corporation II Sep-06-2013
6 Baxa Corporation II Jul-18-2013
7 Baxa Corporation II Apr-13-2012
8 Baxa Corporation II Apr-12-2011
9 Baxa Corporation II Mar-23-2010
10 Baxter Corporation Englewood I Oct-06-2016
11 Baxter Healthcare Corp. II Jul-01-2014
12 Baxter Healthcare Corp. II Nov-26-2013
13 Baxter Healthcare Corp. II Sep-23-2011
14 Baxter Healthcare Corp. II May-25-2011
15 Baxter Healthcare Corp. II Feb-22-2011
16 Baxter Healthcare Corporation I Feb-16-2024
17 Baxter Healthcare Corporation II Aug-24-2022
18 Baxter Healthcare Corporation II Oct-21-2019
19 Baxter Healthcare Corporation II May-22-2018
20 Excelsior Medical Corp II Jul-16-2014
21 International Medical Industries, Inc. II Jan-07-2023
22 Medimop Medical Projects Ltd. II Mar-12-2018
23 Migada Inc. II May-06-2009
24 WEST PHARMA. SERVICES IL, LTD I Jan-28-2019
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