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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
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 7
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 8
GAMBRO
  SUBSTANTIALLY EQUIVALENT 6
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Information 27471
No Known Device Problem 220
No code available 23
Leak 20
Fire 9
Manufacturing or shipping issue associated with device 9
Bacterial contamination of device 8
Device operates differently than expected 7
Mechanical issue 5
Not Applicable 4
Smoking 3
Improper or incorrect procedure or method 2
Calibration issue 2
Nonstandard device or device component 2
Contamination during use 2
No fail-safe mechanism 2
Filtration issue 2
Improper chemical reaction 1
Moisture or humidity problem 1
Charred 1
Disconnection 1
Imprecision 1
Instruction for use issue 1
Normal 1
Chemical spillage 1
Device markings issue 1
Device unsafe to use in environment 1
Patient-device incompatibility 1
Total Device Problems 27802

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 1 0 0
Class II 0 1 1 1 0 1 1 2 3 2
Class III 0 0 0 0 2 0 1 1 0 0

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 Holdings, Inc. III Jan-17-2013
8 Fresenius Medical Care Holdings, Inc. I Jun-25-2012
9 Fresenius Medical Care Holdings, Inc. II May-15-2012
10 Fresenius Medical Care Holdings, Inc. III Jun-10-2011
11 Fresenius Medical Care North America II Aug-15-2010
12 Fresenius Medical Care Renal Therapies Group, LLC II Feb-25-2016
13 Fresenius Medical Care Renal Therapies Group, LLC II Nov-18-2015
14 Isopure Corp III Nov-16-2011
15 NxStage Medical, Inc. II Feb-24-2014
16 NxStage Medical, Inc. II May-02-2013
17 Rockwell Medical Technologies, Inc II Jan-05-2009
18 Rockwell Medical Technologies, Inc II Feb-13-2008

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