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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 2

MDR Year MDR Reports MDR Events
2020 90 90
2021 60 60
2022 55 55
2023 67 67
2024 89 89
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 165 165
Disconnection 40 40
Detachment of Device or Device Component 37 37
No Flow 23 23
Crack 23 23
Filling Problem 20 20
Material Puncture/Hole 20 20
Break 19 19
Backflow 16 16
Material Split, Cut or Torn 11 11
Device Contamination with Chemical or Other Material 11 11
Failure to Disconnect 7 7
Defective Component 5 5
Air/Gas in Device 5 5
Material Twisted/Bent 4 4
Improper Flow or Infusion 4 4
Obstruction of Flow 4 4
Component Missing 4 4
Protective Measures Problem 3 3
Fracture 3 3
Tear, Rip or Hole in Device Packaging 3 3
Failure to Prime 3 3
Misconnection 3 3
Defective Device 3 3
Leak/Splash 3 3
Scratched Material 2 2
Material Perforation 2 2
Material Rupture 2 2
Material Deformation 2 2
Physical Resistance/Sticking 2 2
Free or Unrestricted Flow 2 2
Component Misassembled 2 2
Connection Problem 2 2
Contamination /Decontamination Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Microbial Contamination of Device 1 1
Material Discolored 1 1
Device Difficult to Setup or Prepare 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1
Separation Failure 1 1
Insufficient Flow or Under Infusion 1 1
Structural Problem 1 1
Clumping in Device or Device Ingredient 1 1
Difficult or Delayed Separation 1 1
Complete Blockage 1 1
Filtration Problem 1 1
Reflux within Device 1 1
Material Protrusion/Extrusion 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 259 259
No Consequences Or Impact To Patient 46 46
No Patient Involvement 45 45
Insufficient Information 12 12
No Known Impact Or Consequence To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cardiac Arrest 2 2
Low Blood Pressure/ Hypotension 2 2
Death 1 1
Respiratory Arrest 1 1
Exposure to Body Fluids 1 1

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