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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
DIALYSIS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
DIASOL, INC.
  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 23685
Adverse Event Without Identified Device or Use Problem 270
Thermal Decomposition of Device 57
Smoking 31
Leak / Splash 20
Melted 20
Fire 15
Manufacturing, Packaging or Shipping Problem 10
Appropriate Term/Code Not Available 8
Microbial Contamination of Device 8
Sparking 8
Device Operates Differently Than Expected 7
Improper or Incorrect Procedure or Method 6
Inadequate Ultra Filtration 6
Mechanical Problem 5
Fluid Leak 5
Contamination During Use 5
Off-Label Use 3
Use of Device Problem 2
Corroded 2
Overheating of Device 2
Calibration Problem 2
Spring Loading Mechanism 2
No Apparent Adverse Event 2
No Fail-Safe Mechanism 2
Filtration Problem 2
Improper Chemical Reaction 1
Chemical Spillage 1
Electrical Shorting 1
Inadequate Filtration Process 1
Crack 1
Electrical /Electronic Property Problem 1
Imprecision 1
Labelling, Instructions for Use or Training Problem 1
Inappropriate Shock 1
Nonstandard device 1
Total Device Problems 24195

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 Holdings, Inc. II Sep-23-2014
5 Fresenius Medical Care Holdings, Inc. III Jun-09-2014
6 Fresenius Medical Care Holdings, Inc. I May-22-2014
7 Fresenius Medical Care Renal Therapies Group, LLC III Nov-29-2018
8 Fresenius Medical Care Renal Therapies Group, LLC II Jun-07-2018
9 Fresenius Medical Care Renal Therapies Group, LLC II Mar-14-2018
10 Fresenius Medical Care Renal Therapies Group, LLC II Feb-25-2016
11 Fresenius Medical Care Renal Therapies Group, LLC II Nov-18-2015
12 NxStage Medical, Inc. II Jun-02-2019
13 NxStage Medical, Inc. II Nov-27-2018
14 NxStage Medical, Inc. II Mar-19-2018
15 NxStage Medical, Inc. II Feb-24-2014
16 Rockwell Medical, Inc II May-14-2018

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