• 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 set, administration, for peritoneal dialysis, disposable
Regulation Description Peritoneal dialysis system and accessories.
Product CodeKDJ
Regulation Number 876.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 7
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 13
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 6
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
KLEIN-BAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 1
MILLIPORE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 8706
Improper or incorrect procedure or method 2043
Fluid leak 720
Crack 648
Detachment of device or device component 607
Product quality issue 403
Disconnection 392
Break 205
Loose or intermittent connection 178
Unsealed device packaging 159
Leak 105
Foreign material present in device 103
Connection issue 97
Packaging issue 88
Hole in material 72
Component(s), broken 67
Component missing 67
Detachment of device component 65
Misassembled 43
No Information 42
Fitting problem 37
Device operates differently than expected 36
Device displays error message 32
Tear, rip or hole in device packaging 32
Material separation 32
Use of Device Issue 31
Device packaging compromised 18
Cut in material 14
Failure to disconnect 14
Misconnection 12
Improper flow or infusion 10
Material integrity issue 10
No flow 9
Other (for use when an appropriate device code cannot be identified) 9
Contamination during use 8
Air leak 6
Slippage of device or device component 6
Radiation Underexposure 5
Material deformation 5
Device handling issue 4
Material puncture 4
Nonstandard device or device component 4
Component falling 4
Defective component 4
Material rupture 4
Failure to separate 3
Connection error 3
Bent 3
Degraded 3
Mechanical issue 3
Kinked 3
Not Applicable 3
Sticking 2
Fracture 2
Alarm, audible 2
Defective item 2
Overfill 2
Tube(s), defective 2
Device markings issue 2
Expiration date error 2
Failure to spike 2
Difficult to open or close 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Manufacturing or shipping issue associated with device 1
Bacterial contamination of device 1
Therapy delivered to incorrect body area 1
Insufficient flow or underinfusion 1
Tipover 1
Device alarm system issue 1
Device Cleaning Issue 1
Excess flow or overinfusion 1
Difficult to insert 1
Material discolored 1
Tears, rips, holes in device, device material 1
Peeled 1
Failure to prime 1
Delivered as unsterile product 1
Moisture damage 1
Noise, Audible 1
No code available 1
Total Device Problems 15219

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

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp II Oct-17-2014
2 Baxter Healthcare Corp. II Oct-30-2015
3 Baxter Healthcare Corp. II Aug-27-2015
4 Baxter Healthcare Corp. II Aug-31-2009
5 Baxter Healthcare Corporation II Jun-02-2017

-
-