Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 168 178
Disconnection 58 63
No Flow 28 28
Break 22 22
Crack 22 22
Filling Problem 19 19
Material Puncture/Hole 17 17
Backflow 14 14
Detachment of Device or Device Component 14 14
Device Contamination with Chemical or Other Material 11 11
Material Split, Cut or Torn 10 10
Improper Flow or Infusion 7 8
Failure to Disconnect 7 7
Defective Component 6 6
Component Missing 5 5
Failure to Prime 5 5
Obstruction of Flow 4 4
Reflux within Device 4 4
Material Deformation 4 4
Protective Measures Problem 4 4
Connection Problem 4 4
Material Twisted/Bent 4 4
Air/Gas in Device 3 3
Free or Unrestricted Flow 3 3
Fitting Problem 3 3
Defective Device 3 3
Complete Blockage 3 3
Fracture 3 3
Leak/Splash 3 3
Misconnection 2 2
Contamination /Decontamination Problem 2 2
Separation Failure 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Perforation 2 2
Material Rupture 2 2
Scratched Material 2 2
Physical Resistance/Sticking 2 2
Component Misassembled 2 2
Incomplete or Inadequate Connection 1 1
Incomplete or Inadequate Priming 1 1
Difficult or Delayed Separation 1 1
Unintended Movement 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Infusion or Flow Problem 1 1
Material Separation 1 1
Insufficient Flow or Under Infusion 1 1
Microbial Contamination of Device 1 1
Structural Problem 1 1
Component or Accessory Incompatibility 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Melted 1 1
Clumping in Device or Device Ingredient 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 183 183
No Consequences Or Impact To Patient 87 92
No Patient Involvement 73 75
No Known Impact Or Consequence To Patient 18 25
Insufficient Information 9 9
Cardiac Arrest 2 2
Low Blood Pressure/ Hypotension 2 2
Exposure to Body Fluids 1 1
Respiratory Arrest 1 1
Death 1 1

-
-