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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
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
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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