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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device controller, infusion, intravascular, electronic
Product CodeLDR
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Restricted Flow rate 1 1
Fluid/Blood Leak 1 1
Excess Flow or Over-Infusion 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dizziness 2 2
Numbness 1 1
No Patient Involvement 1 1
Low Blood Pressure/ Hypotension 1 1

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