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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hemodialysis system for home use
Definition To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Product CodeONW
Regulation Number 876.5860
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2020 6 6
2021 7 7
2022 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 10 10
Adverse Event Without Identified Device or Use Problem 3 3
Mechanical Problem 3 3
Reflux within Device 3 3
Leak/Splash 2 2
Unexpected Shutdown 1 1
Material Separation 1 1
Inadequate Ultra Filtration 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
No Known Impact Or Consequence To Patient 8 8
No Patient Involvement 2 2
Air Embolism 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Dizziness 1 1
Numbness 1 1

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