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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reservoir, blood, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass blood reservoir.
Product CodeDTN
Regulation Number 870.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 11
COBE INC.
  SUBSTANTIALLY EQUIVALENT 9
DIDECO
  SUBSTANTIALLY EQUIVALENT 3
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 16
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
JOSTRA
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 11
MINNTECH
  SUBSTANTIALLY EQUIVALENT 2
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYSTAN
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 3
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 14
SORIN
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
Leak 24
Device damaged prior to use 18
Other (for use when an appropriate device code cannot be identified) 16
Fluid leak 16
Component(s), broken 13
Reservoir 12
Device Issue 8
Infusion or flow issue 6
Kinked 5
Replace 4
Device inoperable 4
Detachment of device component 4
Device displays error message 4
Device operates differently than expected 4
Crack 3
Disconnection 3
Hole in material 3
Collapse 2
Occlusion within device 2
Performance 2
Suction issue 2
Failure to pump 2
Decrease in suction 2
Break 2
Electrical issue 2
Filter 2
Filter break(s) 2
Restricted flowrate 2
Connection issue 2
No Known Device Problem 2
Positioning Issue 2
Pressure issue 1
Temperature issue 1
Optical distortion 1
Obstruction within device 1
Device packaging compromised 1
Device sensing issue 1
Electronic property issue 1
Environmental Particulates 1
Filtration issue 1
Foreign material 1
Material fragmentation 1
Heat, failure to 1
Insufficient heating 1
Coagulation in device or device ingredient 1
Air leak 1
Blockage within device or device component 1
Difficult to remove 1
Insufficient flow or underinfusion 1
Increase in pressure 1
Failure to prime 1
Unsealed device packaging 1
Material disintegration 1
Total Device Problems 197

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

Recalls
Manufacturer Recall Class Date Posted
1 Circulatory Technology Inc II Apr-13-2010
2 Medtronic Perfusion Systems II Jul-24-2008
3 Medtronic Perfusion Systems III Jan-26-2008
4 Terumo Cardiovascular Corporation II Aug-04-2011

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