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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device subsystem, water purification
Regulation Description Water purification system for hemodialysis.
Product CodeFIP
Regulation Number 876.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
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 NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS MEDICAL CARE RENTAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAR COR PURIFICATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY WATER TECHNOLOGIES, 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 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 303 303
Fluid/Blood Leak 160 160
Melted 37 37
Sparking 17 17
Arcing 17 17
Smoking 12 12
Break 5 5
Crack 4 4
Disconnection 1 1
Fire 1 1
Output Problem 1 1
Failure to Power Up 1 1
Improper Flow or Infusion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 460 460
No Patient Involvement 18 18
Low Blood Pressure/ Hypotension 7 7
Diaphoresis 3 3
Weight Changes 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Discomfort 2 2
Fatigue 1 1
Itching Sensation 1 1
Numbness 1 1
Insufficient Information 1 1
Dehydration 1 1
Swelling/ Edema 1 1
Convulsion/Seizure 1 1
Hemorrhage/Bleeding 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 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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