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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 controller, infusion, intravascular, electronic
Product CodeLDR
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
DEKA RESEARCH & DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 22 22
2019 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Excess Flow or Over-Infusion 22 22
Leak/Splash 1 1
Insufficient Flow or Under Infusion 1 1
Infusion or Flow Problem 1 1
Restricted Flow rate 1 1
Inaccurate Flow Rate 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 17 17
No Patient Involvement 5 5
Dizziness 2 2
Low Blood Pressure/ Hypotension 1 1
Numbness 1 1
No Known Impact Or Consequence To Patient 1 1
Not Applicable 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConMed Corporation II Feb-28-2018
2 ConMed Corporation II Jan-11-2012
3 ConMed Corporation II Jan-11-2012
4 Leventon S. A. U. II Jun-21-2011
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