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TPLC
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Device
microfilter, blood transfusion
Regulation Description
Intravascular administration set.
Product Code
CAK
Regulation Number
880.5440
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
180
180
2021
18
18
2022
110
110
2023
69
69
2024
19
19
2025
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
355
355
Coagulation in Device or Device Ingredient
73
73
Filtration Problem
70
70
Insufficient Information
65
65
Restricted Flow rate
45
45
Contamination of Device Ingredient or Reagent
41
41
High Readings
39
39
High Test Results
38
38
Defective Component
17
17
Therapeutic or Diagnostic Output Failure
13
13
Inadequate Filtration Process
9
9
No Apparent Adverse Event
5
5
Device Ingredient or Reagent Problem
4
4
Obstruction of Flow
4
4
Use of Device Problem
3
3
Misassembled
3
3
Misassembly by Users
3
3
Improper Chemical Reaction
2
2
Pressure Problem
1
1
Device Damaged Prior to Use
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Contamination /Decontamination Problem
1
1
Device Difficult to Setup or Prepare
1
1
Partial Blockage
1
1
Product Quality Problem
1
1
Fungus in Device Environment
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
252
252
No Patient Involvement
160
160
No Consequences Or Impact To Patient
61
61
No Known Impact Or Consequence To Patient
25
25
Hemolysis
5
5
Insufficient Information
2
2
Perforation of Esophagus
1
1
Alteration in Body Temperature
1
1
Pain
1
1
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