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TPLC
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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 Code
ONW
Regulation Number
876.5860
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Inadequate Ultra Filtration
3
3
Partial Blockage
3
3
Device Displays Incorrect Message
3
3
Disconnection
2
2
Leak/Splash
2
2
Pressure Problem
2
2
Device Alarm System
2
2
Pumping Stopped
2
2
Failure to Deliver
2
2
Failure To Adhere Or Bond
2
2
Unexpected Shutdown
1
1
Pumping Problem
1
1
Filling Problem
1
1
Kinked
1
1
Contamination /Decontamination Problem
1
1
Obstruction of Flow
1
1
Thermal Decomposition of Device
1
1
Misconnection
1
1
Material Separation
1
1
Computer Software Problem
1
1
Fracture
1
1
Power Problem
1
1
Connection Problem
1
1
High pH
1
1
Loose or Intermittent Connection
1
1
Electronic Property Issue
1
1
No Flow
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
Anemia
4
4
Cardiac Arrest
4
4
Pleural Effusion
4
4
Low Blood Pressure/ Hypotension
4
4
Dizziness
3
3
Cardiopulmonary Arrest
3
3
High Blood Pressure/ Hypertension
2
2
Syncope
2
2
No Consequences Or Impact To Patient
2
2
Loss of consciousness
2
2
Air Embolism
1
1
Unspecified Infection
1
1
No Information
1
1
Exsanguination
1
1
Edema
1
1
Chest Pain
1
1
Septic Shock
1
1
Numbness
1
1
Collapse
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Hypovolemia
1
1
Hypervolemia
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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