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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
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 82 82
2018 66 66
2019 85 99
2020 90 90
2021 60 60
2022 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 202 212
Disconnection 72 77
No Flow 25 25
Crack 24 24
Break 20 20
Filling Problem 17 17
Material Puncture/Hole 13 13
Backflow 12 12
Failure to Prime 10 10
Hole In Material 10 10
Device Contamination with Chemical or Other Material 10 10
Cut In Material 9 9
Improper Flow or Infusion 8 9
Connection Problem 7 7
Fitting Problem 6 6
Material Split, Cut or Torn 6 6
Material Deformation 5 5
Reflux within Device 5 5
Defective Component 5 5
Component Missing 5 5
Complete Blockage 5 5
Fracture 4 4
Leak/Splash 4 4
Melted 4 4
Material Rupture 3 3
Material Perforation 3 3
Device Operates Differently Than Expected 3 3
Protective Measures Problem 3 3
Contamination /Decontamination Problem 2 2
Material Twisted/Bent 2 2
Infusion or Flow Problem 2 2
Material Separation 2 2
Tear, Rip or Hole in Device Packaging 2 2
Separation Failure 2 2
Defective Device 2 2
Device Displays Incorrect Message 1 1
Detachment of Device or Device Component 1 1
Structural Problem 1 1
Failure to Disconnect 1 1
Insufficient Flow or Under Infusion 1 1
Product Quality Problem 1 1
Misconnection 1 1
Unsealed Device Packaging 1 1
Device Difficult to Setup or Prepare 1 1
Mechanical Problem 1 1
Gas Output Problem 1 1
Partial Blockage 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Device Packaging Compromised 1 1
Free or Unrestricted Flow 1 1
Incomplete or Inadequate Connection 1 1
Incomplete or Inadequate Priming 1 1
Scratched Material 1 1
Unintended Movement 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 162 167
No Patient Involvement 124 126
No Clinical Signs, Symptoms or Conditions 66 66
No Known Impact Or Consequence To Patient 37 44
Insufficient Information 7 7
No Information 1 1
No Code Available 1 1
Blood Loss 1 1
Exposure to Body Fluids 1 1
Death 1 1

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