Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
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 3
FRESENIUS MEDICAL CARE RENTAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY WATER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 35 35
2022 57 57
2023 140 144
2024 174 177
2025 77 77
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 291 291
Fluid/Blood Leak 170 177
Melted 35 35
Sparking 20 20
Arcing 18 18
Smoking 11 11
Break 6 7
Crack 5 5
Disconnection 1 1
Fire 1 1
Output Problem 1 1
Filtration 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
Material Deformation 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 477 484
Low Blood Pressure/ Hypotension 8 8
No Patient Involvement 6 6
Diaphoresis 4 4
Weight Changes 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Discomfort 2 2
Fatigue 1 1
Itching Sensation 1 1
Pallor 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 Outset Medical, Inc. II Apr-07-2023
-
-