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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, blood, cardiopulmonary bypass, roller type
Regulation Description Roller-type cardiopulmonary bypass blood pump.
Product CodeDWB
Regulation Number 870.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
COBE INC.
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Pumping stopped 21
Other (for use when an appropriate device code cannot be identified) 14
Malfunction 5
Decreased pump speed 4
Increased pump speed 2
Failure to pump 2
Device displays error message 2
Loose or intermittent connection 2
No display or display failure 2
Electrical issue 2
Port leak(s) 2
Failure to power-up 1
Leak 1
Mechanical issue 1
Monitor failure 1
Performance 1
Device operates differently than expected 1
Pumping issue 1
Runaway 1
Noise 1
Tear, rip or hole in device packaging 1
Total Device Problems 68

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

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Cardiovascular Systems Corporation II Nov-29-2011
2 Terumo Cardiovascular Systems Corporation II Sep-15-2011

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