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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, blood transfusion
Product CodeBRZ
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTERIOCYTE MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 108 108
2015 171 171
2016 78 78
2017 82 82
2018 66 66
2019 85 99
2020 90 90
2021 60 60
2022 55 55
2023 67 67
2024 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 382 392
Disconnection 151 156
No Flow 48 48
Break 44 44
Crack 41 41
Leak/Splash 36 36
Filling Problem 35 35
Device Operates Differently Than Expected 30 30
Device Contamination with Chemical or Other Material 26 26
Failure to Prime 25 25
Material Puncture/Hole 22 22
Detachment of Device or Device Component 22 22
Hole In Material 19 19
Detachment Of Device Component 18 18
Material Deformation 16 16
Backflow 16 16
Connection Problem 13 13
Cut In Material 12 12
Material Split, Cut or Torn 10 10
Device Displays Incorrect Message 10 10
Failure to Disconnect 10 10
Improper Flow or Infusion 10 11
Air Leak 10 10
Component Missing 9 9
Material Separation 9 9
Fitting Problem 8 8
Failure to Infuse 8 8
Reflux within Device 7 7
Infusion or Flow Problem 7 7
Defective Component 6 6
Improper or Incorrect Procedure or Method 5 5
Complete Blockage 5 5
Kinked 5 5
Melted 5 5
Obstruction of Flow 5 5
Material Twisted/Bent 4 4
Material Perforation 4 4
Air/Gas in Device 4 4
Material Rupture 4 4
Fracture 4 4
Protective Measures Problem 4 4
Misconnection 3 3
Free or Unrestricted Flow 3 3
Scratched Material 3 3
Contamination /Decontamination Problem 3 3
Material Integrity Problem 3 3
Defective Device 3 3
Component Falling 2 2
Mechanical Problem 2 2
Occlusion Within Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 263 268
No Patient Involvement 260 262
No Clinical Signs, Symptoms or Conditions 221 221
No Known Impact Or Consequence To Patient 145 152
Insufficient Information 10 10
Low Blood Pressure/ Hypotension 4 4
No Information 3 3
Blood Loss 3 3
Exposure to Body Fluids 3 3
Cardiac Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
No Code Available 1 1
Respiratory Arrest 1 1
Inflammation 1 1
Overdose 1 1
Discomfort 1 1
Dyspnea 1 1
Bradycardia 1 1
Reaction 1 1
Shaking/Tremors 1 1
Hemorrhage/Bleeding 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Genesis BPS, LLC. II Sep-18-2014
2 Hospira Inc. I Aug-05-2013
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