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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 2

Device Problems
Device displays error message 62
Pumping stopped 45
No display or display failure 45
Other (for use when an appropriate device code cannot be identified) 33
Device operates differently than expected 26
Break 14
Failure to pump 10
Device stops intermittently 7
Malfunction 5
Pumping issue 4
Decreased pump speed 4
Increased pump speed 4
Device Issue 4
Suction issue 3
Failure to power-up 3
False alarm 3
Incorrect display 3
Loose or intermittent connection 3
Positioning Issue 3
Noise, Audible 2
Failure to auto stop 2
Mechanical issue 2
Fracture 2
Port leak(s) 2
Electrical issue 2
Device alarm system issue 2
Sticking 2
Device markings issue 2
Tear, rip or hole in device packaging 1
Device contamination with blood or blood product 1
Noise 1
Runaway 1
Material rupture 1
Crack 1
Fluid leak 1
Loss of power 1
Leak 1
Monitor failure 1
Performance 1
Material deformation 1
Mechanical jam 1
No flow 1
Difficult to advance 1
Difficult to open or close 1
Fail-safe mechanism issue 1
Power source issue 1
Temperature issue 1
Total Device Problems 318

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