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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 6392
Improper or incorrect procedure or method 1558
Crack 553
Detachment of device or device component 523
Fluid leak 522
Product quality issue 324
Disconnection 281
Break 152
Unsealed device packaging 134
Loose or intermittent connection 129
Leak 99
Connection issue 81
Foreign material present in device 70
Component(s), broken 67
Detachment of device component 62
Hole in material 59
Packaging issue 53
Component missing 53
No Information 42
Misassembled 40
Fitting problem 35
Material separation 32
Use of Device Issue 30
Tear, rip or hole in device packaging 29
Device operates differently than expected 23
Device displays error message 21
Device packaging compromised 15
Failure to disconnect 13
Misconnection 11
Material integrity issue 10
Cut in material 9
Other (for use when an appropriate device code cannot be identified) 9
Contamination during use 8
No flow 7
Air leak 6
Slippage of device or device component 6
Material puncture 4
Nonstandard device or device component 4
Component falling 4
Defective component 4
Material deformation 4
Device handling issue 3
Material rupture 3
Failure to separate 3
Not Applicable 3
Connection error 3
Bent 3
Degraded 3
Mechanical issue 3
Kinked 3
Sticking 2
Fracture 2
Alarm, audible 2
Failure to spike 2
Defective item 2
Overfill 2
Tube(s), defective 2
Bacterial contamination of device 1
Therapy delivered to incorrect body area 1
Insufficient flow or underinfusion 1
Tipover 1
Difficult to open or close 1
Dislodged or dislocated 1
No code available 1
Human-Device Interface Issue 1
Manufacturing or shipping issue associated with device 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
Delivered as unsterile product 1
Moisture damage 1
Noise, Audible 1
Total Device Problems 11538

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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