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TPLC
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show TPLC since
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Device
subsystem, water purification
Product Code
FIP
Regulation Number
876.5665
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CANTEL
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE RENTAL THERAPIES GROUP, LLC
SUBSTANTIALLY EQUIVALENT
1
MAR COR PURIFICATION, INC.
SUBSTANTIALLY EQUIVALENT
2
NEPHROS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
6
6
2018
3
3
2019
13
13
2020
12
12
2021
35
35
2022
25
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
Thermal Decomposition of Device
63
63
Fluid Leak
10
10
Melted
9
9
Sparking
5
5
Arcing
5
5
Smoking
4
4
Fitting Problem
2
2
Microbial Contamination of Device
2
2
Corroded
2
2
Material Disintegration
2
2
Device Displays Incorrect Message
2
2
Misassembly During Maintenance/Repair
2
2
Material Integrity Problem
2
2
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Misassembly by Users
1
1
Device Handling Problem
1
1
Break
1
1
Fire
1
1
Component Incompatible
1
1
Misconnection
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Inadequate Filtration Process
1
1
Defective Component
1
1
Contamination /Decontamination Problem
1
1
Device Contamination With Biological Material
1
1
Device Operates Differently Than Expected
1
1
Improper Flow or Infusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
56
56
No Patient Involvement
25
25
No Known Impact Or Consequence To Patient
8
8
No Information
1
1
Insufficient Information
1
1
Abrasion
1
1
Anemia
1
1
Death
1
1
Hemolysis
1
1
Nerve Damage
1
1
Cramp(s)
1
1
Dizziness
1
1
No Consequences Or Impact To Patient
1
1
Hemolytic Anemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Fresenius Medical Care Holdings, Inc.
II
Jul-25-2022
2
Fresenius Medical Care Holdings, Inc.
II
Jul-11-2022
3
Fresenius Medical Care Holdings, Inc.
II
May-07-2021
4
Fresenius Medical Care Holdings, Inc.
II
Oct-13-2020
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