• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device subsystem, water purification
Regulation Description Water purification system for hemodialysis.
Product CodeFIP
Regulation Number 876.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BETTER WATER, LLC.
  SUBSTANTIALLY EQUIVALENT 1
CANTEL
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAR COR PURIFICATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MED-TECH WATER SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
NEPHROS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 3 3
2017 6 6
2018 3 3
2019 13 13
2020 12 12
2021 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 46 46
Melted 7 7
Arcing 5 5
Smoking 4 4
Sparking 3 3
Fitting Problem 2 2
Microbial Contamination of Device 2 2
Fluid Leak 2 2
Corroded 2 2
Material Disintegration 2 2
Filtration Problem 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Loss of or Failure to Bond 2 2
Misassembly During Maintenance/Repair 2 2
Misassembly by Users 1 1
Device Handling Problem 1 1
Improper Flow or Infusion 1 1
Device Displays Incorrect Message 1 1
Fire 1 1
Component Incompatible 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Misconnection 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
No Patient Involvement 25 25
No Known Impact Or Consequence To Patient 9 9
Patient Problem/Medical Problem 2 2
No 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
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Holdings, Inc. II May-07-2021
2 Fresenius Medical Care Holdings, Inc. II Oct-13-2020
-
-