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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 3532
Improper or incorrect procedure or method 921
Detachment of device or device component 382
Crack 352
Fluid leak 352
Product quality issue 189
Disconnection 172
Break 101
Loose or intermittent connection 85
Leak 80
Component(s), broken 67
Connection issue 64
Detachment of device component 60
Hole in material 49
Foreign material present in device 48
Unsealed device packaging 45
No Information 42
Component missing 35
Misassembled 33
Material separation 32
Packaging issue 32
Use of Device Issue 30
Device operates differently than expected 20
Fitting problem 19
Device displays error message 17
Tear, rip or hole in device packaging 13
Device packaging compromised 10
Material integrity issue 10
Other (for use when an appropriate device code cannot be identified) 9
Misconnection 9
Contamination during use 8
Failure to disconnect 7
Cut in material 6
Air leak 6
Slippage of device or device component 6
Nonstandard device or device component 4
Material puncture 4
Component falling 4
Defective component 4
Failure to separate 3
Not Applicable 3
Device handling issue 3
Connection error 3
Bent 3
Degraded 3
Material rupture 3
Mechanical issue 3
Sticking 2
Fracture 2
Alarm, audible 2
No flow 2
Material deformation 2
Defective item 2
Failure to spike 2
Tube(s), defective 2
Overfill 2
Insufficient flow or underinfusion 1
Bacterial contamination of device 1
Tipover 1
Human-Device Interface Issue 1
Manufacturing or shipping issue associated with device 1
Difficult to open or close 1
Dislodged or dislocated 1
Noise, Audible 1
No code available 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
Moisture damage 1
Peeled 1
Total Device Problems 6918

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