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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, tubing, blood, with and without anti-regurgitation valve
Regulation Description Hemodialysis system and accessories.
Product CodeFJK
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 4
GAMBRO
  SUBSTANTIALLY EQUIVALENT 5
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 2
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 125
Fluid leak 114
Material separation 100
Kinked 96
No Information 47
Leak 46
Unknown (for use when the device problem is not known) 32
Disconnection 31
Air leak 15
Hole in material 15
Detachment of device component 14
Normal 12
Not Applicable 11
Connection issue 11
Other (for use when an appropriate device code cannot be identified) 10
No code available 9
Defective component 9
Device operates differently than expected 8
Cut in material 8
Loose or intermittent connection 8
Crack 7
Misconnection 7
Use of Device Issue 7
Dislodged or dislocated 6
Occlusion within device 6
Overdelivery 6
Method, improper/incorrect 6
Loss of or failure to bond 5
Coagulation in device or device ingredient 4
Device alarm system issue 4
Source, detachment from 3
Failure to Adhere or Bond 3
Tip breakage 3
Decoupling 2
Migration of device or device component 2
Increase in pressure 2
Break 2
Filtration issue 2
Mechanical issue 2
Defective Alarm 2
Material rupture 2
Device damaged prior to use 2
Device maintenance issue 2
Decrease in pressure 2
Blockage within device or device component 1
Foreign material present in device 1
Inadequate filtration process 1
Unit inactivated 1
Device Issue 1
Restricted flowrate 1
Reaction 1
Detachment of device or device component 1
Alarm system, failure of check-catheter 1
Improper flow or infusion 1
Component(s), broken 1
Tube(s), shattering of 1
Split 1
Suction issue 1
Couple, failure to 1
Filter 1
Connector pin failure 1
Infusion or flow issue 1
Fracture 1
Dislocated 1
Patient-device incompatibility 1
Emergency stop button or switch failure 1
Tube(s), defective 1
Improper or incorrect procedure or method 1
Total Device Problems 834

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 1 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0 1 0 1 0
Class III 0 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. III May-07-2008
2 Fresenius Medical Care Holdings, Inc. I Jan-10-2011
3 Gambro Renal Products, Inc. II Sep-26-2008
4 Gambro Renal Products, Incorporated II Apr-11-2014
5 Nipro Medical Corporation II Jan-08-2016

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