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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
Regulation Description Intravascular administration set.
Product CodeCAK
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2021 18 18
2022 110 110
2023 69 69
2024 19 19
2025 62 62
2026 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 280 280
Insufficient Information 84 84
Contamination of Device Ingredient or Reagent 41 41
Filtration Problem 27 27
High Test Results 20 20
Inadequate Filtration Process 9 9
No Apparent Adverse Event 4 4
High Readings 3 3
Defective Component 3 3
Coagulation in Device or Device Ingredient 2 2
Filling Problem 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Damaged Prior to Use 1 1
Partial Blockage 1 1
Fungus in Device Environment 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 305 305
Hemolysis 4 4
Insufficient Information 3 3
Nausea 1 1
Dizziness 1 1
Alteration in Body Temperature 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GVS TM, Inc II Jan-22-2026
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