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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
Product CodeBRZ
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 85 99
2020 90 90
2021 60 60
2022 55 55
2023 67 67
2024 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 185 195
Disconnection 58 63
No Flow 29 29
Break 25 25
Crack 23 23
Filling Problem 23 23
Material Puncture/Hole 21 21
Detachment of Device or Device Component 21 21
Backflow 16 16
Device Contamination with Chemical or Other Material 12 12
Material Split, Cut or Torn 10 10
Improper Flow or Infusion 7 8
Failure to Disconnect 7 7
Defective Component 6 6
Failure to Prime 5 5
Component Missing 5 5
Air/Gas in Device 4 4
Reflux within Device 4 4
Obstruction of Flow 4 4
Material Twisted/Bent 4 4
Material Deformation 4 4
Protective Measures Problem 4 4
Connection Problem 4 4
Leak/Splash 3 3
Fitting Problem 3 3
Complete Blockage 3 3
Free or Unrestricted Flow 3 3
Defective Device 3 3
Misconnection 3 3
Fracture 3 3
Component Misassembled 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Perforation 2 2
Physical Resistance/Sticking 2 2
Material Rupture 2 2
Contamination /Decontamination Problem 2 2
Scratched Material 2 2
Separation Failure 2 2
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Melted 1 1
Difficult or Delayed Separation 1 1
Material Integrity Problem 1 1
Material Discolored 1 1
Device Difficult to Setup or Prepare 1 1
Microbial Contamination of Device 1 1
Incomplete or Inadequate Connection 1 1
Mechanical Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 221 221
No Consequences Or Impact To Patient 87 92
No Patient Involvement 73 75
No Known Impact Or Consequence To Patient 18 25
Insufficient Information 10 10
Cardiac Arrest 2 2
Low Blood Pressure/ Hypotension 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Respiratory Arrest 1 1
Exposure to Body Fluids 1 1

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