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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, hemodialysis, remote accessories
Product CodeMON
Regulation Number 876.5820
Device Class 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 10 10
2021 2 2
2022 19 19
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 45 45
Leak/Splash 1 1
Decrease in Pressure 1 1
Defective Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 21 21
No Clinical Signs, Symptoms or Conditions 21 21
No Patient Involvement 3 3
Low Blood Pressure/ Hypotension 3 3
Bacterial Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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