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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, hemoperfusion, sorbent
Product CodeFLD
Regulation Number 876.5870
Device Class 2

MDR Year MDR Reports MDR Events
2019 6 6
2020 3 3
2021 6 6
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 5 5
Device Contamination with Chemical or Other Material 4 4
Leak/Splash 3 3
Patient Device Interaction Problem 2 2
Disconnection 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 5 5
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 2 2
Ventilator Dependent 1 1
Respiratory Failure 1 1
Blood Loss 1 1
Anaphylactic Shock 1 1
Cardiac Arrest 1 1
Hemorrhage/Bleeding 1 1
Hypoxia 1 1
Shock 1 1
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1
Thrombocytopenia 1 1

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