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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 6098
Improper or incorrect procedure or method 1483
Crack 544
Fluid leak 506
Detachment of device or device component 472
Product quality issue 324
Disconnection 270
Break 142
Loose or intermittent connection 123
Leak 99
Unsealed device packaging 81
Connection issue 81
Foreign material present in device 69
Component(s), broken 67
Detachment of device component 62
Hole in material 58
Packaging issue 53
No Information 42
Component missing 41
Misassembled 40
Fitting problem 35
Material separation 32
Use of Device Issue 30
Tear, rip or hole in device packaging 24
Device operates differently than expected 22
Device displays error message 20
Device packaging compromised 15
Failure to disconnect 13
Misconnection 11
Material integrity issue 10
Other (for use when an appropriate device code cannot be identified) 9
Cut in material 9
Contamination during use 8
No flow 6
Slippage of device or device component 6
Air leak 6
Nonstandard device or device component 4
Component falling 4
Material puncture 4
Defective component 4
Bent 3
Degraded 3
Not Applicable 3
Material rupture 3
Mechanical issue 3
Connection error 3
Device handling issue 3
Failure to separate 3
Material deformation 2
Sticking 2
Defective item 2
Overfill 2
Failure to spike 2
Alarm, audible 2
Fracture 2
Tube(s), defective 2
Material discolored 1
Tears, rips, holes in device, device material 1
Human-Device Interface Issue 1
Device Cleaning Issue 1
Delivered as unsterile product 1
Dislodged or dislocated 1
Tipover 1
Difficult to open or close 1
No code available 1
Noise, Audible 1
Bacterial contamination of device 1
Insufficient flow or underinfusion 1
Manufacturing or shipping issue associated with device 1
Difficult to insert 1
Device alarm system issue 1
Moisture damage 1
Kinked 1
Therapy delivered to incorrect body area 1
Peeled 1
Excess flow or overinfusion 1
Total Device Problems 10987

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 0
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

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