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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 7412
Improper or incorrect procedure or method 1776
Crack 617
Fluid leak 599
Detachment of device or device component 582
Product quality issue 358
Disconnection 320
Break 183
Loose or intermittent connection 155
Unsealed device packaging 152
Leak 99
Connection issue 88
Foreign material present in device 87
Component(s), broken 67
Detachment of device component 65
Hole in material 64
Component missing 61
Packaging issue 53
No Information 42
Misassembled 42
Fitting problem 37
Material separation 32
Tear, rip or hole in device packaging 31
Use of Device Issue 30
Device operates differently than expected 26
Device displays error message 24
Device packaging compromised 16
Failure to disconnect 13
Cut in material 12
Misconnection 12
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
Material deformation 5
Material puncture 4
Nonstandard device or device component 4
Component falling 4
Defective component 4
Material rupture 3
Failure to separate 3
Not Applicable 3
Connection error 3
Bent 3
Degraded 3
Mechanical issue 3
Kinked 3
Device handling issue 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
Failure to prime 1
Delivered as unsterile product 1
Moisture damage 1
Noise, Audible 1
Total Device Problems 13185

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

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