• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 1948
Device operates differently than expected 1017
Mechanical issue 982
Reflux within device 977
No Known Device Problem 306
Fluid leak 222
Product quality issue 197
Leak 152
Dialyzer, failure of 108
Crack 103
Detachment of device or device component 89
Normal 79
Disconnection 49
No code available 42
Rupture, cause unknown 40
Connection issue 39
Device alarm system issue 38
Coagulation in device or device ingredient 35
Ultrafiltration 33
Other (for use when an appropriate device code cannot be identified) 27
Unknown (for use when the device problem is not known) 25
Improper or incorrect procedure or method 22
Fire 16
Contamination during use 15
Use of Device Issue 15
Smoking 15
Component missing 15
Filter leak(s) 15
Burn of device or device component 15
Detachment of device component 15
Calibration issue 14
Device clogged 13
Not Applicable 13
Break 12
Device handling issue 11
Device Issue 10
Inaccurate delivery 9
Device displays error message 9
Defective component 9
Patient-device incompatibility 8
Pumping stopped 8
Failure to disconnect 8
Calibration error 8
Bacterial contamination of device 7
Misassembled by Users 7
False reading from device non-compliance 7
Infusion or flow issue 7
Material separation 6
Filtration issue 6
Biocompatibility issue 6
Volume accuracy issue 5
Loose or intermittent connection 5
Air leak 5
Foreign material present in device 5
Dislodged 5
Device inoperable 5
Material integrity issue 4
Device Cleaning Issue 4
Spark 4
Occlusion within device 4
Chemical reaction 4
Failure to pump 4
Not audible alarm 4
Inadequate filtration process 4
Accuracy rate 4
Excess flow or overinfusion 4
User used incorrect product for intended use 4
Component falling 4
Imprecision 4
Split 4
Improper flow or infusion 4
Dissection 3
Cut in material 3
Charred 3
Defective Alarm 3
Material rupture 3
Failure to power-up 3
Loss of power 3
Conductivity 3
Output, high 3
Dialysate 3
No display or display failure 3
Electrical issue 3
Pressure sensor failure 3
High Readings 3
Inaccurate flowrate 3
Misconnection 3
Power source issue 2
Decoupling 2
Electro-static discharge 2
Failure to sense 2
Interference with monitoring device 2
Burst 2
Misassembled 2
Increase in pressure 2
Material frayed 2
Particulates 2
Artifact 2
Electrical shorting 2
Device maintenance issue 2
Total Device Problems 6993

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 1
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 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 Jan-13-2017
25 Fresenius Medical Care Renal Therapies Group, LLC II Apr-05-2016
26 Gambro Renal Products Inc II Dec-01-2014
27 Gambro Renal Products, Inc. II Mar-25-2008
28 Gambro Renal Products, Inc. II Mar-31-2007
29 Gambro Renal Products, Incorporated II Aug-13-2014
30 Gambro Renal Products, Incorporated II May-21-2014
31 Gambro Renal Products, Incorporated II Apr-06-2011
32 Medivators, Inc. II Sep-11-2015
33 Medtronic Perfusion Systems II Sep-04-2015
34 NxStage Medical, Inc. II Nov-25-2015
35 NxStage Medical, Inc. II Nov-23-2015
36 NxStage Medical, Inc. II Sep-20-2007

-
-