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TPLC
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show TPLC since
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Device
set, blood transfusion
Product Code
BRZ
Regulation Number
880.5440
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
168
178
Disconnection
66
71
No Flow
21
21
Crack
19
19
Filling Problem
17
17
Break
17
17
Material Puncture/Hole
16
16
Backflow
13
13
Device Contamination with Chemical or Other Material
11
11
Failure to Prime
9
9
Improper Flow or Infusion
8
9
Material Split, Cut or Torn
7
7
Component Missing
5
5
Connection Problem
5
5
Complete Blockage
5
5
Material Deformation
5
5
Leak/Splash
5
5
Reflux within Device
5
5
Defective Component
5
5
Fitting Problem
4
4
Fracture
3
3
Hole In Material
3
3
Protective Measures Problem
3
3
Scratched Material
3
3
Detachment of Device or Device Component
3
3
Melted
3
3
Material Perforation
2
2
Defective Device
2
2
Failure to Disconnect
2
2
Contamination /Decontamination Problem
2
2
Material Rupture
2
2
Material Twisted/Bent
2
2
Material Separation
2
2
Separation Failure
2
2
Tear, Rip or Hole in Device Packaging
2
2
Misconnection
1
1
Product Quality Problem
1
1
Partial Blockage
1
1
Clumping in Device or Device Ingredient
1
1
Material Discolored
1
1
Material Integrity Problem
1
1
Unintended Movement
1
1
Incomplete or Inadequate Connection
1
1
Air/Gas in Device
1
1
Infusion or Flow Problem
1
1
Material Protrusion/Extrusion
1
1
Unsealed Device Packaging
1
1
Insufficient Flow or Under Infusion
1
1
Loose or Intermittent Connection
1
1
Free or Unrestricted Flow
1
1
Component Misassembled
1
1
Structural Problem
1
1
Incomplete or Inadequate Priming
1
1
Device Difficult to Setup or Prepare
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
126
131
No Clinical Signs, Symptoms or Conditions
103
103
No Patient Involvement
91
93
No Known Impact Or Consequence To Patient
25
32
Insufficient Information
7
7
Exposure to Body Fluids
1
1
Death
1
1
No Information
1
1
No Code Available
1
1
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