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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device microfilter, blood transfusion
Product CodeCAK
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
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 594 594
Coagulation in Device or Device Ingredient 302 302
Filtration Problem 129 129
Restricted Flow rate 101 101
Defective Component 77 77
High Readings 59 59
High Test Results 56 56
Contamination of Device Ingredient or Reagent 43 43
Insufficient Information 43 43
Therapeutic or Diagnostic Output Failure 21 21
Product Quality Problem 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Inadequate Filtration Process 6 6
No Apparent Adverse Event 5 5
Device Ingredient or Reagent Problem 4 4
Misassembly by Users 3 3
Obstruction of Flow 3 3
Defective Device 3 3
Use of Device Problem 3 3
Misassembled 3 3
Contamination /Decontamination Problem 2 2
Break 2 2
Device Contamination with Body Fluid 2 2
Improper Chemical Reaction 2 2
Appropriate Term/Code Not Available 2 2
Pressure Problem 1 1
Fungus in Device Environment 1 1
Device Difficult to Setup or Prepare 1 1
Fluid/Blood Leak 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 494 494
No Known Impact Or Consequence To Patient 277 277
No Clinical Signs, Symptoms or Conditions 213 213
No Consequences Or Impact To Patient 70 70
Hemolysis 5 5
Insufficient Information 2 2
Alteration in Body Temperature 1 1
Pain 1 1
Perforation of Esophagus 1 1

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