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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
Regulation Description Intravascular administration set.
Product CodeBRZ
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 78 78
2017 82 82
2018 66 66
2019 85 99
2020 90 90
2021 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 223 233
Disconnection 90 95
No Flow 27 27
Crack 24 24
Break 18 18
Filling Problem 16 16
Hole In Material 14 14
Failure to Prime 13 13
Device Contamination with Chemical or Other Material 12 12
Material Puncture/Hole 11 11
Cut In Material 11 11
Improper Flow or Infusion 8 9
Connection Problem 8 8
Material Deformation 7 7
Fitting Problem 7 7
Reflux within Device 6 6
Backflow 6 6
Material Separation 5 5
Material Split, Cut or Torn 5 5
Device Operates Differently Than Expected 4 4
Device Displays Incorrect Message 4 4
Component Missing 4 4
Failure to Infuse 4 4
Complete Blockage 4 4
Fracture 4 4
Leak/Splash 4 4
Melted 4 4
Material Rupture 3 3
Protective Measures Problem 3 3
Infusion or Flow Problem 2 2
Defective Component 2 2
Contamination /Decontamination Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Kinked 2 2
Gas Output Problem 1 1
Misconnection 1 1
Unsealed Device Packaging 1 1
Mechanical Problem 1 1
Partial Blockage 1 1
Difficult to Flush 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Defective Device 1 1
Product Quality Problem 1 1
Insufficient Flow or Under Infusion 1 1
Material Perforation 1 1
Incomplete or Inadequate Connection 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Aspiration Issue 1 1
Device Packaging Compromised 1 1
Detachment of Device or Device Component 1 1
Free or Unrestricted Flow 1 1
Scratched Material 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 196 201
No Patient Involvement 144 146
No Known Impact Or Consequence To Patient 59 66
No Clinical Signs, Symptoms or Conditions 36 36
Insufficient Information 3 3
Exposure to Body Fluids 2 2
Bradycardia 1 1
Death 1 1
Blood Loss 1 1
No Information 1 1
No Code Available 1 1

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