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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
BETTER WATER, LLC.
  SUBSTANTIALLY EQUIVALENT 1
CANTEL
  SUBSTANTIALLY EQUIVALENT 1
EVOQUA WATER TECHNOLOGIES LLC
  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 2
MED-TECH WATER SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
NEPHROS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY WATER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
VIVONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 11 11
2016 3 3
2017 6 6
2018 3 3
2019 13 13
2020 12 12
2021 35 35
2022 57 57
2023 140 140
2024 102 102

Device Problems MDRs with this Device Problem Events in those MDRs
Thermal Decomposition of Device 255 255
Fluid/Blood Leak 86 86
Melted 31 31
Arcing 15 15
Smoking 10 10
Sparking 10 10
Crack 4 4
Contamination /Decontamination Problem 3 3
Break 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Corroded 3 3
Overheating of Device 3 3
Material Integrity Problem 2 2
Material Disintegration 2 2
Filtration Problem 2 2
Fire 2 2
Loss of or Failure to Bond 2 2
Device Displays Incorrect Message 2 2
Device Reprocessing Problem 2 2
Flushing Problem 2 2
Device Emits Odor 2 2
Misassembly During Maintenance/Repair 2 2
Microbial Contamination of Device 2 2
Fitting Problem 2 2
Device Inoperable 1 1
Component Incompatible 1 1
Loose or Intermittent Connection 1 1
Electrical /Electronic Property Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Inadequate Filtration Process 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1
Device Operates Differently Than Expected 1 1
Fracture 1 1
Device Alarm System 1 1
Device Contamination With Biological Material 1 1
Leak/Splash 1 1
Defective Component 1 1
Device Handling Problem 1 1
Misassembly by Users 1 1
Misconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 324 324
No Patient Involvement 25 25
No Known Impact Or Consequence To Patient 13 13
Low Blood Pressure/ Hypotension 4 4
Hemolysis 3 3
No Consequences Or Impact To Patient 3 3
Patient Problem/Medical Problem 2 2
No Code Available 2 2
Weight Changes 1 1
Death 1 1
Diaphoresis 1 1
No Information 1 1
Dizziness 1 1
Blood Loss 1 1
Chemical Exposure 1 1
Abrasion 1 1
Anemia 1 1
Itching Sensation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Hemolytic Anemia 1 1
Nerve Damage 1 1
Cramp(s) 1 1
Insufficient Information 1 1
Discomfort 1 1
Numbness 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1
Loss of consciousness 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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