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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microfilter, blood transfusion
Product CodeCAK
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 661 661
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 213 213
No Consequences Or Impact To Patient 71 71
Hemolysis 25 25
No Information 11 11
Needle Stick/Puncture 6 6
Low Blood Pressure/ Hypotension 5 5
Reaction 4 4
Insufficient Information 2 2
Pain 2 2
Perforation of Esophagus 1 1
Alteration in Body Temperature 1 1
Exposure to Body Fluids 1 1

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