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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, blood circuit, hemodialysis
Regulation Description Hemodialysis system and accessories.
Product CodeKOC
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
NIKKISO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2020 20 20
2021 33 33
2022 26 26
2023 16 16
2024 18 18
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 91 91
Thermal Decomposition of Device 11 11
Patient Device Interaction Problem 7 7
Fire 5 5
Smoking 4 4
Melted 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Leak/Splash 1 1
Break 1 1
Material Twisted/Bent 1 1
Structural Problem 1 1
Detachment of Device or Device Component 1 1
Computer Software Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 56 56
Hemorrhage/Bleeding 32 32
No Known Impact Or Consequence To Patient 17 17
Genital Bleeding 7 7
Insufficient Information 3 3
Low Blood Pressure/ Hypotension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Patient Involvement 2 2
Respiratory Failure 2 2
Abdominal Pain 1 1
Exsanguination 1 1
Anemia 1 1
Cardiac Arrest 1 1
Cardiogenic Shock 1 1
Hypothermia 1 1
Renal Impairment 1 1
Loss of consciousness 1 1

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