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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 2

MDR Year MDR Reports MDR Events
2018 66 66
2019 85 99
2020 90 90
2021 60 60
2022 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 168 178
Disconnection 66 71
No Flow 21 21
Crack 19 19
Filling Problem 17 17
Break 17 17
Material Puncture/Hole 16 16
Backflow 13 13
Device Contamination with Chemical or Other Material 11 11
Failure to Prime 9 9
Improper Flow or Infusion 8 9
Material Split, Cut or Torn 7 7
Component Missing 5 5
Connection Problem 5 5
Complete Blockage 5 5
Material Deformation 5 5
Leak/Splash 5 5
Reflux within Device 5 5
Defective Component 5 5
Fitting Problem 4 4
Fracture 3 3
Hole In Material 3 3
Protective Measures Problem 3 3
Scratched Material 3 3
Detachment of Device or Device Component 3 3
Melted 3 3
Material Perforation 2 2
Defective Device 2 2
Failure to Disconnect 2 2
Contamination /Decontamination Problem 2 2
Material Rupture 2 2
Material Twisted/Bent 2 2
Material Separation 2 2
Separation Failure 2 2
Tear, Rip or Hole in Device Packaging 2 2
Misconnection 1 1
Product Quality Problem 1 1
Partial Blockage 1 1
Clumping in Device or Device Ingredient 1 1
Material Discolored 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1
Incomplete or Inadequate Connection 1 1
Air/Gas in Device 1 1
Infusion or Flow Problem 1 1
Material Protrusion/Extrusion 1 1
Unsealed Device Packaging 1 1
Insufficient Flow or Under Infusion 1 1
Loose or Intermittent Connection 1 1
Free or Unrestricted Flow 1 1
Component Misassembled 1 1
Structural Problem 1 1
Incomplete or Inadequate Priming 1 1
Device Difficult to Setup or Prepare 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 126 131
No Clinical Signs, Symptoms or Conditions 103 103
No Patient Involvement 91 93
No Known Impact Or Consequence To Patient 25 32
Insufficient Information 7 7
Exposure to Body Fluids 1 1
Death 1 1
No Information 1 1
No Code Available 1 1

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