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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
2018 5 5
2019 5 5
2020 1 1
2022 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Crack 6 6
Leak/Splash 5 5
Gas/Air Leak 2 2
Failure to Infuse 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 1 1
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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