• 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 dialysate concentrate for hemodialysis (liquid or powder)
Regulation Description Hemodialysis system and accessories.
Product CodeKPO
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BELLCO SRL
  SUBSTANTIALLY EQUIVALENT 1
DI-CHEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
ROCKWELL MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 8087
Adverse Event Without Identified Device or Use Problem 220
Thermal Decomposition of Device 60
Smoking 35
Melted 23
Leak / Splash 20
Fire 15
Manufacturing, Packaging or Shipping Problem 10
Microbial Contamination of Device 8
Sparking 8
Device Operates Differently Than Expected 7
Appropriate Term/Code Not Available 7
Fluid Leak 7
Inadequate Ultra Filtration 6
Contamination During Use 5
Mechanical Problem 5
Improper or Incorrect Procedure or Method 4
Off-Label Use 3
Calibration Problem 2
Overheating of Device 2
Spring Loading Mechanism 2
Corroded 2
No Apparent Adverse Event 2
Use of Device Problem 2
Electrical /Electronic Property Problem 1
Inappropriate Shock 1
Improper Chemical Reaction 1
Imprecision 1
Nonstandard device 1
Labelling, Instructions for Use or Training Problem 1
Crack 1
Inadequate Filtration Process 1
Electrical Shorting 1
Total Device Problems 8551

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Jun-24-2016
2 Fresenius Medical Care Holdings, Inc. II Aug-12-2015
3 Fresenius Medical Care Holdings, Inc. II Jun-22-2015
4 Fresenius Medical Care Renal Therapies Group, LLC III Nov-29-2018
5 Fresenius Medical Care Renal Therapies Group, LLC II Jun-07-2018
6 Fresenius Medical Care Renal Therapies Group, LLC II Mar-14-2018
7 Fresenius Medical Care Renal Therapies Group, LLC II Feb-25-2016
8 Fresenius Medical Care Renal Therapies Group, LLC II Nov-18-2015
9 Isopure Corp II Jan-19-2020
10 NxStage Medical, Inc. II Jun-02-2019
11 NxStage Medical, Inc. II Nov-27-2018
12 NxStage Medical, Inc. II Mar-19-2018
13 Rockwell Medical, Inc II May-14-2018

-
-