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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 8
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 27475
No Known Device Problem 253
No code available 23
Leak 20
Fire 13
Burn of device or device component 12
Manufacturing or shipping issue associated with device 10
Smoking 8
Bacterial contamination of device 8
Device operates differently than expected 7
Mechanical issue 5
Not Applicable 4
Melted 3
Spark 3
Calibration issue 2
Improper or incorrect procedure or method 2
Nonstandard device or device component 2
Contamination during use 2
Filtration issue 2
User used incorrect product for intended use 2
No fail-safe mechanism 2
Moisture or humidity problem 1
Improper chemical reaction 1
Device unsafe to use in environment 1
Electrical shorting 1
Disconnection 1
Charred 1
Normal 1
Imprecision 1
Instruction for use issue 1
Chemical spillage 1
Device markings issue 1
Patient-device incompatibility 1
Total Device Problems 27870

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 1 0 1 0 0 0
Class II 0 1 1 1 0 1 1 2 3 2 0
Class III 0 0 0 0 2 0 1 1 0 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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