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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

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

Device Problems MDRs with this Device Problem Events in those MDRs
Excess Flow or Over-Infusion 21 21
Insufficient Flow or Under Infusion 1 1
Infusion or Flow Problem 1 1
Restricted Flow rate 1 1
Inaccurate Flow Rate 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
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
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