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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 5412
Improper or incorrect procedure or method 1354
Crack 479
Fluid leak 465
Detachment of device or device component 454
Product quality issue 258
Disconnection 241
Break 140
Loose or intermittent connection 118
Leak 95
Connection issue 77
Unsealed device packaging 75
Component(s), broken 67
Foreign material present in device 64
Detachment of device component 60
Hole in material 54
Packaging issue 48
No Information 42
Component missing 39
Misassembled 39
Fitting problem 33
Material separation 32
Use of Device Issue 30
Device operates differently than expected 21
Device displays error message 19
Tear, rip or hole in device packaging 18
Device packaging compromised 14
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 8
Contamination during use 8
Air leak 6
Slippage of device or device component 6
Defective component 4
Component falling 4
Nonstandard device or device component 4
Material puncture 4
Material rupture 3
Mechanical issue 3
Connection error 3
Bent 3
Degraded 3
Failure to separate 3
No flow 3
Not Applicable 3
Device handling issue 3
Material deformation 2
Failure to spike 2
Defective item 2
Overfill 2
Tube(s), defective 2
Sticking 2
Alarm, audible 2
Fracture 2
Moisture damage 1
Therapy delivered to incorrect body area 1
Delivered as unsterile product 1
Peeled 1
Device alarm system issue 1
Device Cleaning Issue 1
Material discolored 1
Excess flow or overinfusion 1
Difficult to insert 1
Kinked 1
Tears, rips, holes in device, device material 1
Bacterial contamination of device 1
Insufficient flow or underinfusion 1
Tipover 1
Difficult to open or close 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Manufacturing or shipping issue associated with device 1
Noise, Audible 1
No code available 1
Total Device Problems 9898

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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