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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
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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