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TPLC
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Device
subsystem, water purification
Regulation Description
Water purification system for hemodialysis.
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
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
1
MDR Year
MDR Reports
MDR Events
2020
12
12
2021
35
35
2022
57
57
2023
140
140
2024
174
174
2025
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Thermal Decomposition of Device
297
297
Fluid/Blood Leak
118
118
Melted
36
36
Arcing
16
16
Sparking
12
12
Smoking
8
8
Break
5
5
Crack
4
4
Fire
1
1
Device Displays Incorrect Message
1
1
Improper Flow or Infusion
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
406
406
No Patient Involvement
18
18
Low Blood Pressure/ Hypotension
6
6
Diaphoresis
3
3
Cramp(s) /Muscle Spasm(s)
2
2
Weight Changes
2
2
Discomfort
2
2
Convulsion/Seizure
1
1
Insufficient Information
1
1
Hemorrhage/Bleeding
1
1
Itching Sensation
1
1
Dehydration
1
1
Numbness
1
1
Swelling/ Edema
1
1
Fatigue
1
1
Loss of consciousness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Fresenius Medical Care Holdings, Inc.
II
Jun-13-2024
2
Fresenius Medical Care Holdings, Inc.
II
Sep-19-2022
3
Fresenius Medical Care Holdings, Inc.
II
Jul-25-2022
4
Fresenius Medical Care Holdings, Inc.
II
Jul-11-2022
5
Fresenius Medical Care Holdings, Inc.
II
May-07-2021
6
Fresenius Medical Care Holdings, Inc.
II
Oct-13-2020
7
Outset Medical, Inc.
II
Apr-07-2023
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