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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 2

MDR Year MDR Reports MDR Events
2020 20 20
2021 33 33
2022 26 26
2023 16 16
2024 18 18
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 87 87
Thermal Decomposition of Device 11 11
Patient Device Interaction Problem 7 7
Fire 5 5
Smoking 4 4
Melted 3 3
Leak/Splash 1 1
Break 1 1
Material Twisted/Bent 1 1
Structural Problem 1 1
Adverse Event Without Identified Device or Use 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 28 28
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
Anemia 1 1
Cardiogenic Shock 1 1
Hypothermia 1 1
Renal Impairment 1 1
Loss of consciousness 1 1

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