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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dialyzer, high permeability with or without sealed dialysate system
Regulation Description High permeability hemodialysis system.
Product CodeKDI
Regulation Number 876.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
AKSYS LTD
  SUBSTANTIALLY EQUIVALENT 1
ASAHI
  SUBSTANTIALLY EQUIVALENT 8
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 23
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHF SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 10
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
DIDECO
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 22
GAMBRO
  SUBSTANTIALLY EQUIVALENT 42
HOSPAL INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINNTECH
  SUBSTANTIALLY EQUIVALENT 11
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 5
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 21
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Information 1919
Device operates differently than expected 1008
Mechanical issue 976
Reflux within device 971
No Known Device Problem 290
Fluid leak 210
Product quality issue 197
Leak 133
Dialyzer, failure of 108
Detachment of device or device component 89
Crack 88
Normal 79
Disconnection 42
Rupture, cause unknown 40
No code available 40
Device alarm system issue 37
Coagulation in device or device ingredient 33
Ultrafiltration 28
Other (for use when an appropriate device code cannot be identified) 27
Connection issue 27
Unknown (for use when the device problem is not known) 25
Improper or incorrect procedure or method 22
Fire 16
Filter leak(s) 15
Detachment of device component 15
Contamination during use 15
Component missing 15
Use of Device Issue 14
Calibration issue 14
Not Applicable 13
Break 12
Device handling issue 11
Smoking 10
Device Issue 10
Defective component 9
Inaccurate delivery 9
Device displays error message 9
Failure to disconnect 8
Patient-device incompatibility 8
Calibration error 8
Device clogged 8
False reading from device non-compliance 7
Bacterial contamination of device 7
Misassembled by Users 7
Infusion or flow issue 7
Filtration issue 6
Biocompatibility issue 6
Material separation 5
Device inoperable 5
Volume accuracy issue 5
Loose or intermittent connection 5
Dislodged 5
Foreign material present in device 5
Material integrity issue 4
Component falling 4
Chemical reaction 4
Device Cleaning Issue 4
Air leak 4
Not audible alarm 4
Imprecision 4
Excess flow or overinfusion 4
Occlusion within device 4
Accuracy rate 4
User used incorrect product for intended use 4
Failure to pump 4
Pumping stopped 4
Spark 4
Split 4
Inadequate filtration process 4
High Readings 3
Cut in material 3
Loss of power 3
Failure to power-up 3
Pressure sensor failure 3
Material rupture 3
Output, high 3
Misconnection 3
Inaccurate flowrate 3
Dialysate 3
Dissection 3
Electrical issue 3
Defective Alarm 3
Burn of device or device component 3
No display or display failure 3
Conductivity 3
Improper flow or infusion 3
Power source issue 2
Use of Incorrect Control Settings 2
Measurements, inaccurate 2
Computer software issue 2
Component(s), broken 2
Burst 2
Alarm, failure of warning 2
Artifact 2
Decoupling 2
Restricted flowrate 2
Material frayed 2
Device maintenance issue 2
Interference with monitoring device 2
Nonstandard device or device component 2
Total Device Problems 6821

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 1
Class II 2 2 1 2 3 3 3 9 7 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Asahi Kasei Medical Co., Ltd., Okatomi Plant II Sep-20-2012
2 B Braun Medical Inc I May-03-2016
3 Baxter Healthcare Corp. II Mar-13-2015
4 Baxter Healthcare Corp. II Jul-17-2014
5 Baxter Healthcare Corp. II Jun-30-2014
6 Baxter Healthcare Corp. II Jun-21-2013
7 Baxter Healthcare Renal Div II Nov-07-2011
8 Baxter Healthcare Renal Div II Nov-12-2009
9 Edwards Lifesciences, Llc I Jan-27-2010
10 Fresenius Medical Care Holdings, Inc. II Apr-29-2015
11 Fresenius Medical Care Holdings, Inc. II Jan-27-2015
12 Fresenius Medical Care Holdings, Inc. II May-13-2014
13 Fresenius Medical Care Holdings, Inc. II Feb-26-2014
14 Fresenius Medical Care Holdings, Inc. II Feb-03-2014
15 Fresenius Medical Care Holdings, Inc. II Jan-06-2014
16 Fresenius Medical Care Holdings, Inc. II Jul-11-2013
17 Fresenius Medical Care Holdings, Inc. II Mar-30-2012
18 Fresenius Medical Care Holdings, Inc. II Jan-20-2012
19 Fresenius Medical Care Holdings, Inc. II Mar-22-2011
20 Fresenius Medical Care Holdings, Inc. dba Renal Solutions II Aug-26-2013
21 Fresenius Medical Care North America II Aug-15-2010
22 Fresenius Medical Care North America II Jul-01-2010
23 Fresenius Medical Care North America II Feb-01-2008
24 Fresenius Medical Care Renal Therapies Group, LLC II Apr-05-2016
25 Gambro Renal Products Inc II Dec-01-2014
26 Gambro Renal Products, Inc. II Mar-25-2008
27 Gambro Renal Products, Inc. II Mar-31-2007
28 Gambro Renal Products, Incorporated II Aug-13-2014
29 Gambro Renal Products, Incorporated II May-21-2014
30 Gambro Renal Products, Incorporated II Apr-06-2011
31 Medivators, Inc. II Sep-11-2015
32 Medtronic Perfusion Systems II Sep-04-2015
33 NxStage Medical, Inc. II Nov-25-2015
34 NxStage Medical, Inc. II Nov-23-2015
35 NxStage Medical, Inc. II Sep-20-2007

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