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TPLC
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show TPLC since
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2024
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Device
microfilter, blood transfusion
Product Code
CAK
Regulation Number
880.5440
Device Class
2
Premarket Reviews
Manufacturer
Decision
MACOPRODUCTIONS S.A.S.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
36
36
2015
58
58
2016
97
97
2017
131
131
2018
58
58
2019
334
334
2020
180
180
2021
18
18
2022
110
110
2023
69
69
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
653
653
Coagulation in Device or Device Ingredient
302
302
Filtration Problem
228
228
Defective Component
163
163
High Test Results
137
137
Restricted Flow rate
105
105
High Readings
76
76
Device Operates Differently Than Expected
75
75
Contamination of Device Ingredient or Reagent
53
53
Insufficient Information
51
51
Therapeutic or Diagnostic Output Failure
21
21
Device Contamination with Body Fluid
19
19
Incorrect Or Inadequate Test Results
17
17
Material Discolored
12
12
Incorrect, Inadequate or Imprecise Result or Readings
12
12
Material Integrity Problem
12
12
Product Quality Problem
10
10
Inadequate Filtration Process
10
10
Free or Unrestricted Flow
8
8
Device Ingredient or Reagent Problem
7
7
Contamination
6
6
Protective Measures Problem
5
5
No Apparent Adverse Event
5
5
Appropriate Term/Code Not Available
4
4
Improper Flow or Infusion
4
4
Use of Device Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Misassembled
3
3
Defective Device
3
3
Obstruction of Flow
3
3
Misassembly by Users
3
3
Human-Device Interface Problem
2
2
Improper Chemical Reaction
2
2
Clumping in Device or Device Ingredient
2
2
Contamination /Decontamination Problem
2
2
Break
2
2
Device Expiration Issue
2
2
Fluid/Blood Leak
2
2
Burst Container or Vessel
1
1
Nonstandard Device
1
1
Device Difficult to Setup or Prepare
1
1
Difficult to Remove
1
1
Device Damaged Prior to Use
1
1
Device Operational Issue
1
1
Fail-Safe Problem
1
1
Fungus in Device Environment
1
1
Invalid Sensing
1
1
Improper Device Output
1
1
No Flow
1
1
Pressure Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
778
778
No Known Impact Or Consequence To Patient
330
330
No Clinical Signs, Symptoms or Conditions
209
209
No Consequences Or Impact To Patient
71
71
Hemolysis
21
21
No Information
11
11
Needle Stick/Puncture
6
6
Low Blood Pressure/ Hypotension
5
5
Reaction
4
4
Pain
2
2
Insufficient Information
2
2
Exposure to Body Fluids
1
1
Alteration in Body Temperature
1
1
Perforation of Esophagus
1
1
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