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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 9
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 24
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 23
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 6
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 23
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Information 1956
Device operates differently than expected 1041
Mechanical issue 1002
Reflux within device 998
No Known Device Problem 470
Fluid leak 388
Leak 204
Product quality issue 197
Crack 114
Dialyzer, failure of 108
Burn of device or device component 101
Ultrafiltration 100
Detachment of device or device component 89
Normal 79
Disconnection 59
Connection issue 51
No code available 44
Rupture, cause unknown 40
Device alarm system issue 38
Coagulation in device or device ingredient 38
Smoking 34
Charred 29
Other (for use when an appropriate device code cannot be identified) 27
Unknown (for use when the device problem is not known) 25
Melted 25
Improper or incorrect procedure or method 23
Detachment of device component 19
Fire 18
Use of Device Issue 18
Pumping stopped 17
Break 17
Calibration issue 16
Device clogged 15
Contamination during use 15
Filter leak(s) 15
Component missing 15
Spark 14
Not Applicable 13
Device handling issue 11
Device displays error message 11
Patient-device incompatibility 11
Defective component 11
Loose or intermittent connection 11
Device Issue 10
Filtration issue 10
Pumping issue 9
Inaccurate delivery 9
Failure to disconnect 8
Calibration error 8
False reading from device non-compliance 7
Bacterial contamination of device 7
Misassembled by Users 7
Infusion or flow issue 7
Foreign material present in device 6
Biocompatibility issue 6
Device inoperable 6
Air leak 6
Dislodged 5
Material separation 5
Occlusion within device 5
Split 5
Volume accuracy issue 5
Improper flow or infusion 5
Material integrity issue 4
Inadequate filtration process 4
Misconnection 4
Overheating of device or device component 4
User used incorrect product for intended use 4
Failure to pump 4
Material rupture 4
Accuracy rate 4
Imprecision 4
Excess flow or overinfusion 4
Not audible alarm 4
Device Cleaning Issue 4
Chemical reaction 4
Component falling 4
Conductivity 3
Defective Alarm 3
Bent 3
Inaccurate flowrate 3
No display or display failure 3
Electrical issue 3
Dissection 3
Dialysate 3
Loss of power 3
Failure to power-up 3
Pressure sensor failure 3
Output, high 3
Cut in material 3
High Readings 3
Failure to sense 2
Electro-static discharge 2
Nonstandard device or device component 2
Increase in pressure 2
Incorrect or inadequate result 2
Particulates 2
Restricted flowrate 2
Misassembled 2
Device maintenance issue 2
Total Device Problems 7779

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 1 0 0 0 0 0 1 0
Class II 2 2 1 2 3 3 3 9 7 1 2
Class III 0 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 Corporation II Jan-25-2017
8 Baxter Healthcare Renal Div II Nov-07-2011
9 Baxter Healthcare Renal Div II Nov-12-2009
10 Edwards Lifesciences, Llc I Jan-27-2010
11 Fresenius Medical Care Holdings, Inc. II Apr-29-2015
12 Fresenius Medical Care Holdings, Inc. II Jan-27-2015
13 Fresenius Medical Care Holdings, Inc. II May-13-2014
14 Fresenius Medical Care Holdings, Inc. II Feb-26-2014
15 Fresenius Medical Care Holdings, Inc. II Feb-03-2014
16 Fresenius Medical Care Holdings, Inc. II Jan-06-2014
17 Fresenius Medical Care Holdings, Inc. II Jul-11-2013
18 Fresenius Medical Care Holdings, Inc. II Mar-30-2012
19 Fresenius Medical Care Holdings, Inc. II Jan-20-2012
20 Fresenius Medical Care Holdings, Inc. II Mar-22-2011
21 Fresenius Medical Care Holdings, Inc. dba Renal Solutions II Aug-26-2013
22 Fresenius Medical Care North America II Aug-15-2010
23 Fresenius Medical Care North America II Jul-01-2010
24 Fresenius Medical Care North America II Feb-01-2008
25 Fresenius Medical Care Renal Therapies Group, LLC II Jan-13-2017
26 Fresenius Medical Care Renal Therapies Group, LLC II Apr-05-2016
27 Gambro Renal Products Inc II Dec-01-2014
28 Gambro Renal Products, Inc. II Mar-25-2008
29 Gambro Renal Products, Inc. II Mar-31-2007
30 Gambro Renal Products, Incorporated II Aug-13-2014
31 Gambro Renal Products, Incorporated II May-21-2014
32 Gambro Renal Products, Incorporated II Apr-06-2011
33 Medivators, Inc. II Sep-11-2015
34 Medtronic Perfusion Systems II Sep-04-2015
35 NxStage Medical, Inc. II Nov-25-2015
36 NxStage Medical, Inc. II Nov-23-2015
37 NxStage Medical, Inc. II Sep-20-2007

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