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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
2026 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 167 168
Detachment of Device or Device Component 55 56
Crack 24 24
No Flow 24 24
Backflow 18 18
Filling Problem 17 17
Break 17 17
Material Puncture/Hole 14 14
Disconnection 14 14
Device Contamination with Chemical or Other Material 10 10
Material Split, Cut or Torn 10 10
Failure to Disconnect 9 9
Protective Measures Problem 9 9
Air/Gas in Device 8 8
Obstruction of Flow 5 5
Fitting Problem 4 4
False Alarm 3 3
Material Twisted/Bent 3 3
Defective Component 3 3
Component Misassembled 2 2
Scratched Material 2 2
Free or Unrestricted Flow 2 2
Insufficient Flow or Under Infusion 2 2
Material Perforation 2 2
Component Missing 2 2
Tear, Rip or Hole in Device Packaging 2 2
Misconnection 2 2
Device Alarm System 1 1
Complete Blockage 1 1
Clumping in Device or Device Ingredient 1 1
Material Integrity Problem 1 1
Filtration Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Excess Flow or Over-Infusion 1 1
Improper or Incorrect Procedure or Method 1 1
Microbial Contamination of Device 1 1
Connection Problem 1 1
Defective Device 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Failure to Prime 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 365 366
Insufficient Information 13 13
No Patient Involvement 3 3
No Consequences Or Impact To Patient 3 3
Low Blood Pressure/ Hypotension 2 2
Cardiac Arrest 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Respiratory Arrest 1 1
Exposure to Body Fluids 1 1

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