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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, blood, cardiopulmonary bypass, arterial line
Regulation Description Cardiopulmonary bypass arterial line blood filter.
Product CodeDTM
Regulation Number 870.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COBE INC.
  SUBSTANTIALLY EQUIVALENT 3
DIDECO
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 10
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 3
SORIN
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 9

Device Problems
Leak 28
Fluid leak 27
Other (for use when an appropriate device code cannot be identified) 7
Particulates 6
Filter break(s) 4
Infusion or flow issue 3
Filtration issue 2
Pressure issue 2
Increase in pressure 2
Material separation 2
Device damaged prior to use 2
Crack 2
Blockage within device or device component 2
Break 1
Burst 1
Component(s), broken 1
Detachment of device component 1
Filter leak(s) 1
Fracture 1
Dislodged or dislocated 1
Occlusion within device 1
Use of Device Issue 1
Device handling issue 1
Free or unrestricted flow 1
No Known Device Problem 1
Total Device Problems 101

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 1 0 0 0 0 2 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-14-2013
2 Medtronic Perfusion Systems II Jul-24-2008
3 Terumo Cardiovascular Systems Corporation II Sep-20-2013

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