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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
AMERIWATER, LLC
SUBSTANTIALLY EQUIVALENT
1
B. BRAUN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CANTEL
SUBSTANTIALLY EQUIVALENT
1
EVOQUA WATER TECHNOLOGIES LLC
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
MDR Year
MDR Reports
MDR Events
2018
3
3
2019
13
13
2020
12
12
2021
35
35
2022
57
57
2023
116
116
Device Problems
MDRs with this Device Problem
Events in those MDRs
Thermal Decomposition of Device
169
169
Fluid/Blood Leak
47
47
Melted
21
21
Arcing
9
9
Sparking
7
7
Smoking
5
5
Fitting Problem
2
2
Microbial Contamination of Device
2
2
Material Disintegration
2
2
Corroded
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
Device Handling Problem
1
1
Break
1
1
Improper Flow or Infusion
1
1
Crack
1
1
Component Incompatible
1
1
Fire
1
1
Leak/Splash
1
1
Inadequate Filtration Process
1
1
Device Displays Incorrect Message
1
1
Defective Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
204
204
No Patient Involvement
23
23
No Known Impact Or Consequence To Patient
7
7
Insufficient Information
1
1
Abrasion
1
1
Anemia
1
1
Hemolysis
1
1
Nerve Damage
1
1
Cramp(s)
1
1
Dizziness
1
1
Hemolytic Anemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Fresenius Medical Care Holdings, Inc.
II
Sep-19-2022
2
Fresenius Medical Care Holdings, Inc.
II
Jul-25-2022
3
Fresenius Medical Care Holdings, Inc.
II
Jul-11-2022
4
Fresenius Medical Care Holdings, Inc.
II
May-07-2021
5
Fresenius Medical Care Holdings, Inc.
II
Oct-13-2020
6
Outset Medical, Inc.
II
Apr-07-2023
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