• 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 6
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 21
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
No Information 1951
Device operates differently than expected 1019
Mechanical issue 984
Reflux within device 979
No Known Device Problem 309
Fluid leak 228
Product quality issue 197
Leak 168
Dialyzer, failure of 108
Crack 106
Detachment of device or device component 89
Normal 79
Disconnection 49
Connection issue 42
No code available 42
Rupture, cause unknown 40
Device alarm system issue 38
Ultrafiltration 37
Coagulation in device or device ingredient 35
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
Burn of device or device component 22
Detachment of device component 19
Smoking 17
Fire 16
Filter leak(s) 15
Contamination during use 15
Use of Device Issue 15
Component missing 15
Calibration issue 14
Not Applicable 13
Device clogged 13
Break 12
Device handling issue 11
Device Issue 10
Device displays error message 9
Defective component 9
Inaccurate delivery 9
Pumping stopped 9
Failure to disconnect 8
Patient-device incompatibility 8
Calibration error 8
False reading from device non-compliance 7
Loose or intermittent connection 7
Bacterial contamination of device 7
Misassembled by Users 7
Infusion or flow issue 7
Filtration issue 6
Biocompatibility issue 6
Spark 6
Material separation 6
Device inoperable 5
Volume accuracy issue 5
Dislodged 5
Charred 5
Air leak 5
Foreign material present in device 5
Split 4
Material integrity issue 4
Improper flow or infusion 4
Not audible alarm 4
Chemical reaction 4
Device Cleaning Issue 4
Component falling 4
Imprecision 4
Excess flow or overinfusion 4
Inadequate filtration process 4
Material rupture 4
Accuracy rate 4
User used incorrect product for intended use 4
Failure to pump 4
Occlusion within device 4
Output, high 3
Loss of power 3
Failure to power-up 3
Pressure sensor failure 3
Cut in material 3
High Readings 3
Misconnection 3
No display or display failure 3
Electrical issue 3
Dissection 3
Inaccurate flowrate 3
Conductivity 3
Dialysate 3
Defective Alarm 3
Pumping issue 3
Power source issue 2
Pressure issue 2
Electrical shorting 2
Device disinfection or sterilization issue 2
Measurements, inaccurate 2
Burst 2
Alarm, failure of warning 2
Artifact 2
Decoupling 2
Computer software issue 2
Use of Incorrect Control Settings 2
Component(s), broken 2
Total Device Problems 7059

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

-
-