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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hemodialysis system for home use
Definition To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Product CodeONW
Regulation Number 876.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 35 35
2015 28 28
2016 19 19
2017 11 11
2018 12 12
2019 3 3
2020 6 6
2021 7 7
2022 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 43 43
Fluid/Blood Leak 27 27
Device Operates Differently Than Expected 24 24
Mechanical Problem 23 23
Reflux within Device 19 19
Use of Device Problem 4 4
Mechanical Jam 4 4
Device Displays Incorrect Message 3 3
Inadequate Ultra Filtration 3 3
Partial Blockage 3 3
Device Alarm System 2 2
Failure To Adhere Or Bond 2 2
Disconnection 2 2
Pumping Stopped 2 2
Leak/Splash 2 2
Failure to Deliver 2 2
Pressure Problem 2 2
Pumping Problem 1 1
Unexpected Shutdown 1 1
No Flow 1 1
Power Problem 1 1
Obstruction of Flow 1 1
High pH 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Electronic Property Issue 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Material Separation 1 1
Filling Problem 1 1
Fracture 1 1
Kinked 1 1
Thermal Decomposition of Device 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 43 43
Death 22 22
No Patient Involvement 21 21
Blood Loss 17 17
No Clinical Signs, Symptoms or Conditions 9 9
Pleural Effusion 4 4
Anemia 4 4
Cardiac Arrest 4 4
Low Blood Pressure/ Hypotension 4 4
Dizziness 3 3
Cardiopulmonary Arrest 3 3
No Consequences Or Impact To Patient 2 2
Syncope 2 2
High Blood Pressure/ Hypertension 2 2
Loss of consciousness 2 2
Septic Shock 1 1
Hypervolemia 1 1
No Information 1 1
Air Embolism 1 1
Unspecified Infection 1 1
Hypovolemia 1 1
Numbness 1 1
Collapse 1 1
Chest Pain 1 1
Edema 1 1
Exsanguination 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Holdings, Inc. II Nov-08-2013
2 Fresenius Medical Care Holdings, Inc. II Aug-29-2011
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