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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 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 3
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 3
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
WEST PHARMACEUTICAL SERVICES, 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 639 639

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 5277 5365
Device Contamination with Chemical or Other Material 1753 1815
Leak/Splash 381 381
Device Displays Incorrect Message 256 256
Infusion or Flow Problem 223 223
Break 207 207
Protective Measures Problem 142 142
Disconnection 138 143
Material Puncture/Hole 132 132
Contamination /Decontamination Problem 123 123
Defective Device 119 119
Defective Component 84 84
Device Alarm System 81 81
Free or Unrestricted Flow 76 76
Nonstandard Device 76 76
Device Operates Differently Than Expected 74 74
Air/Gas in Device 66 66
Output Problem 64 64
Hole In Material 53 53
Detachment of Device or Device Component 51 51
Therapeutic or Diagnostic Output Failure 49 49
Contamination 39 39
No Flow 36 36
Difficult to Open or Close 36 36
Improper Flow or Infusion 35 35
Insufficient Information 33 33
Crack 32 32
Material Rupture 31 31
Connection Problem 30 30
Loose or Intermittent Connection 28 28
Tear, Rip or Hole in Device Packaging 27 27
Display or Visual Feedback Problem 26 26
Unsealed Device Packaging 24 26
Component Missing 23 23
Failure to Align 21 21
Chemical Spillage 21 21
Detachment Of Device Component 20 20
Material Separation 20 20
Excess Flow or Over-Infusion 18 18
Material Perforation 18 18
Material Split, Cut or Torn 18 18
Delivered as Unsterile Product 16 16
Pressure Problem 16 16
Product Quality Problem 15 15
Fitting Problem 15 15
Particulates 14 14
Complete Blockage 14 14
Filling Problem 14 14
Device Markings/Labelling Problem 14 14
Backflow 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 4074 4170
No Clinical Signs, Symptoms or Conditions 3649 3649
No Consequences Or Impact To Patient 629 633
No Known Impact Or Consequence To Patient 619 675
Insufficient Information 488 488
No Information 80 80
Dyspnea 34 34
Headache 29 29
Chemical Exposure 23 23
No Code Available 19 19
Dizziness 17 17
Pain 16 16
Diarrhea 12 12
Fatigue 11 11
Nausea 10 10
Fever 9 9
Unspecified Infection 9 9
Hemorrhage/Bleeding 8 8
Malaise 8 8
Chest Pain 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Swelling/ Edema 4 4
Hot Flashes/Flushes 4 4
Unspecified Respiratory Problem 3 3
Underdose 3 3
Cough 3 3
Anxiety 3 3
Arrhythmia 3 3
Tachycardia 3 3
Blood Loss 3 3
Vomiting 3 3
Hypoxia 2 2
Hypoglycemia 2 2
Eye Injury 2 2
Respiratory Insufficiency 2 2
Premature Labor 2 2
Low Blood Pressure/ Hypotension 2 2
Laceration(s) 2 2
Low Oxygen Saturation 2 2
Decreased Appetite 2 2
Exposure to Body Fluids 2 2
Hypervolemia 2 2
Foreign Body In Patient 2 2
Needle Stick/Puncture 2 2
Abdominal Pain 2 2
Syncope/Fainting 2 2
Electrolyte Imbalance 2 2
Itching Sensation 2 2
Purulent Discharge 2 2
Sepsis 2 2

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 Sep-19-2024
17 Baxter Healthcare Corporation I Feb-16-2024
18 Baxter Healthcare Corporation II Aug-24-2022
19 Baxter Healthcare Corporation II Oct-21-2019
20 Baxter Healthcare Corporation II May-22-2018
21 Excelsior Medical Corp II Jul-16-2014
22 International Medical Industries, Inc. II Jan-07-2023
23 Medimop Medical Projects Ltd. II Mar-12-2018
24 Migada Inc. II May-06-2009
25 WEST PHARMA. SERVICES IL, LTD I Jan-28-2019
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