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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 56
2023 67 67
2024 89 89
2025 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 189 190
Detachment of Device or Device Component 44 45
Disconnection 41 41
Crack 28 28
No Flow 27 27
Break 22 22
Backflow 21 21
Material Puncture/Hole 21 21
Filling Problem 20 20
Device Contamination with Chemical or Other Material 13 13
Material Split, Cut or Torn 12 12
Failure to Disconnect 9 9
Air/Gas in Device 8 8
Protective Measures Problem 5 5
Defective Component 5 5
Leak/Splash 4 4
Component Missing 4 4
Obstruction of Flow 4 4
Improper Flow or Infusion 4 4
Material Twisted/Bent 4 4
Fitting Problem 3 3
Defective Device 3 3
Fracture 3 3
Insufficient Flow or Under Infusion 3 3
Tear, Rip or Hole in Device Packaging 3 3
Misconnection 3 3
Failure to Prime 3 3
Connection Problem 2 2
Scratched Material 2 2
Component Misassembled 2 2
Physical Resistance/Sticking 2 2
Free or Unrestricted Flow 2 2
Material Perforation 2 2
Material Rupture 2 2
Material Deformation 2 2
Component or Accessory Incompatibility 1 1
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Incomplete or Inadequate Priming 1 1
Material Protrusion/Extrusion 1 1
Mechanical Problem 1 1
Reflux within Device 1 1
Material Separation 1 1
Difficult or Delayed Separation 1 1
Infusion or Flow Problem 1 1
Structural Problem 1 1
Excess Flow or Over-Infusion 1 1
Device Difficult to Setup or Prepare 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 310 311
No Consequences Or Impact To Patient 46 46
No Patient Involvement 45 45
Insufficient Information 13 13
No Known Impact Or Consequence To Patient 3 3
Low Blood Pressure/ Hypotension 2 2
Cardiac Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Respiratory Arrest 1 1
Death 1 1
Exposure to Body Fluids 1 1

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