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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
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
2019 56 56
2020 20 20
2021 33 33
2022 26 26
2023 16 16
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 94 94
Thermal Decomposition of Device 18 18
Adverse Event Without Identified Device or Use Problem 15 15
Smoking 13 13
Nonstandard Device 12 12
Patient Device Interaction Problem 7 7
Overheating of Device 5 5
Fire 5 5
Device Emits Odor 3 3
Melted 3 3
Inaccurate Information 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Noise, Audible 1 1
Material Puncture/Hole 1 1
Structural Problem 1 1
Device Displays Incorrect Message 1 1
Detachment of Device or Device Component 1 1
Material Twisted/Bent 1 1
Break 1 1
Leak/Splash 1 1
Computer Software Problem 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
No Known Impact Or Consequence To Patient 50 50
Hemolysis 14 14
Hemorrhage/Bleeding 10 10
Genital Bleeding 7 7
No Patient Involvement 4 4
Insufficient Information 3 3
Low Blood Pressure/ Hypotension 3 3
Hypothermia 2 2
No Consequences Or Impact To Patient 2 2
Respiratory Failure 2 2
Burn, Thermal 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Partial thickness (Second Degree) Burn 2 2
Renal Impairment 1 1
Blood Loss 1 1
Abdominal Pain 1 1
Anemia 1 1
Cardiac Arrest 1 1
Cardiogenic Shock 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stihler Electronic Gmbh II Jan-23-2019
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