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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heat-exchanger, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass heat exchanger.
Product CodeDTR
Regulation Number 870.4240
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
COBE INC.
  SUBSTANTIALLY EQUIVALENT 3
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 10
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINNTECH
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCIMED
  SUBSTANTIALLY EQUIVALENT 4
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 11
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 24
Blockage within device or device component 10
Flare or flash 5
Device Issue 3
Fluid leak 2
Hole in material 1
Crack 1
Migration of device or device component 1
Pumping stopped 1
Difficult to remove 1
Sticking 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Tear, rip or hole in device packaging 1
Device operates differently than expected 1
Pressure issue 1
Total Device Problems 55

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 2 0 0 0
Class III 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Quest Medical, Inc III Apr-08-2011
2 Terumo Cardiovascular Corporation II Sep-29-2010
3 Terumo Cardiovascular Systems Corp II Aug-02-2010

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