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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 66
No display or display failure 55
Pumping stopped 46
Other (for use when an appropriate device code cannot be identified) 33
Device operates differently than expected 26
Failure to pump 19
Break 14
Device stops intermittently 7
Device Issue 5
Malfunction 5
Pumping issue 4
Decreased pump speed 4
Increased pump speed 4
Failure to power-up 3
Suction issue 3
False alarm 3
Incorrect display 3
Loose or intermittent connection 3
Positioning Issue 3
Failure to auto stop 3
Noise, Audible 2
Mechanical issue 2
Fracture 2
Port leak(s) 2
Electrical issue 2
Device alarm system issue 2
Detachment of device component 2
Sticking 2
Device markings issue 2
Tear, rip or hole in device packaging 1
Component missing 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
Power source issue 1
Temperature issue 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
Total Device Problems 347

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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