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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, dialysate delivery, single patient
Product CodeFKP
Regulation Number 876.5820
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fungal Infection 4 4
Edema 1 1

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