• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 106
Material separation 100
Kinked 95
Leak 45
No Information 43
Unknown (for use when the device problem is not known) 32
Disconnection 31
Hole in material 15
Detachment of device component 14
Air leak 12
Normal 12
Connection issue 11
Not Applicable 11
Other (for use when an appropriate device code cannot be identified) 10
Defective component 9
No code available 9
Device operates differently than expected 8
Cut in material 8
Loose or intermittent connection 8
Misconnection 7
Use of Device Issue 7
Overdelivery 6
Method, improper/incorrect 6
Crack 6
Loss of or failure to bond 5
Occlusion within device 5
Dislodged or dislocated 5
Coagulation in device or device ingredient 4
Device alarm system issue 4
Failure to Adhere or Bond 3
Source, detachment from 3
Tip breakage 3
Material rupture 2
Device damaged prior to use 2
Filtration issue 2
Decrease in pressure 2
Increase in pressure 2
Migration of device or device component 2
Device maintenance issue 2
Mechanical issue 2
Defective Alarm 2
Break 2
Decoupling 2
Connector pin failure 1
Couple, failure to 1
Dislocated 1
Emergency stop button or switch failure 1
Filter 1
Restricted flowrate 1
Component(s), broken 1
Blockage within device or device component 1
Fracture 1
Reaction 1
Alarm system, failure of check-catheter 1
Foreign material present in device 1
Improper flow or infusion 1
Infusion or flow issue 1
Tube(s), shattering of 1
Unit inactivated 1
Improper or incorrect procedure or method 1
Suction issue 1
Device Issue 1
Tube(s), defective 1
Inadequate filtration process 1
Split 1
Patient-device incompatibility 1
Detachment of device or device component 1
Total Device Problems 814

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

-
-