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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
2018 66 66
2019 85 99
2020 90 90
2021 60 60
2022 55 55
2023 67 67
2024 89 89
2025 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 240 250
Disconnection 72 77
Detachment of Device or Device Component 40 40
No Flow 38 38
Break 29 29
Crack 26 26
Filling Problem 24 24
Material Puncture/Hole 24 24
Backflow 19 19
Device Contamination with Chemical or Other Material 15 15
Material Split, Cut or Torn 11 11
Failure to Prime 9 9
Improper Flow or Infusion 8 9
Failure to Disconnect 7 7
Air/Gas in Device 7 7
Fitting Problem 6 6
Connection Problem 6 6
Defective Component 6 6
Component Missing 6 6
Leak/Splash 5 5
Reflux within Device 5 5
Complete Blockage 5 5
Material Deformation 5 5
Protective Measures Problem 4 4
Obstruction of Flow 4 4
Material Twisted/Bent 4 4
Hole In Material 3 3
Melted 3 3
Fracture 3 3
Free or Unrestricted Flow 3 3
Defective Device 3 3
Tear, Rip or Hole in Device Packaging 3 3
Scratched Material 3 3
Misconnection 3 3
Component Misassembled 2 2
Material Separation 2 2
Material Rupture 2 2
Material Perforation 2 2
Contamination /Decontamination Problem 2 2
Material Integrity Problem 2 2
Separation Failure 2 2
Physical Resistance/Sticking 2 2
Structural Problem 1 1
Infusion or Flow Problem 1 1
Insufficient Flow or Under Infusion 1 1
Device Difficult to Setup or Prepare 1 1
Difficult or Delayed Separation 1 1
Partial Blockage 1 1
Material Discolored 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 277 277
No Consequences Or Impact To Patient 126 131
No Patient Involvement 91 93
No Known Impact Or Consequence To Patient 25 32
Insufficient Information 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cardiac Arrest 2 2
Exposure to Body Fluids 2 2
Low Blood Pressure/ Hypotension 2 2
Death 1 1
No Code Available 1 1
Respiratory Arrest 1 1
No Information 1 1

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