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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
2021 60 60
2022 55 56
2023 67 67
2024 89 89
2025 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 150 151
Detachment of Device or Device Component 46 47
No Flow 23 23
Crack 22 22
Break 19 19
Backflow 18 18
Filling Problem 17 17
Material Puncture/Hole 15 15
Disconnection 13 13
Device Contamination with Chemical or Other Material 11 11
Failure to Disconnect 9 9
Material Split, Cut or Torn 9 9
Air/Gas in Device 8 8
Protective Measures Problem 7 7
Defective Component 5 5
Obstruction of Flow 4 4
Defective Device 3 3
Material Twisted/Bent 3 3
Insufficient Flow or Under Infusion 3 3
Fitting Problem 3 3
Scratched Material 2 2
Component Missing 2 2
Material Perforation 2 2
False Alarm 2 2
Misconnection 2 2
Tear, Rip or Hole in Device Packaging 2 2
Physical Resistance/Sticking 2 2
Free or Unrestricted Flow 2 2
Component Misassembled 2 2
Connection Problem 2 2
Leak/Splash 2 2
Clumping in Device or Device Ingredient 1 1
Separation Failure 1 1
Material Integrity Problem 1 1
Contamination 1 1
Microbial Contamination of Device 1 1
Contamination /Decontamination Problem 1 1
Complete Blockage 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Filtration Problem 1 1
Material Discolored 1 1
Device Difficult to Setup or Prepare 1 1
Excess Flow or Over-Infusion 1 1
Infusion or Flow Problem 1 1
Difficult or Delayed Separation 1 1
Failure to Prime 1 1
Material Separation 1 1
Mechanical Problem 1 1
Material Protrusion/Extrusion 1 1
Incomplete or Inadequate Priming 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 318 319
Insufficient Information 13 13
No Patient Involvement 3 3
No Consequences Or Impact 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
Respiratory Arrest 1 1
Exposure to Body Fluids 1 1

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