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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device subsystem, proportioning
Regulation Description Hemodialysis system and accessories.
Product CodeFKR
Regulation Number 876.5820
Device Class 2

MDR Year MDR Reports MDR Events
2022 3 5
2023 2 2
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Fire 2 2
Therapeutic or Diagnostic Output Failure 1 2
Flare or Flash 1 1
Failure to Prime 1 2
Priming Problem 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 7
Dizziness 3 3
Urticaria 1 1
Arrhythmia 1 1
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Discomfort 1 1
Numbness 1 1
Alteration in Body Temperature 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Failure 1 1

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