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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 kit, repair, catheter, hemodialysis
Definition Hemodialysis Tray
Product CodeNFK
Regulation Number 876.5540
Device Class 2

MDR Year MDR Reports MDR Events
2017 8 8
2018 5 5
2019 5 5
2020 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 8 8
Leak/Splash 7 7
Material Integrity Problem 2 2
Gas Leak 2 2
Break 2 2
Fluid Leak 1 1
Device Operates Differently Than Expected 1 1
Detachment Of Device Component 1 1
Failure to Infuse 1 1
Device Contamination With Biological Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 14 14
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Aug-13-2020
2 Medical Components, Inc dba MedComp II Mar-19-2018
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