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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 56
Pumping stopped 44
No display or display failure 42
Other (for use when an appropriate device code cannot be identified) 33
Device operates differently than expected 26
Break 14
Failure to pump 9
Device stops intermittently 7
Malfunction 5
Increased pump speed 4
Device Issue 4
Pumping issue 4
Decreased pump speed 4
Suction issue 3
False alarm 3
Failure to power-up 3
Incorrect display 3
Positioning Issue 3
Loose or intermittent connection 3
Device markings issue 2
Device alarm system issue 2
Mechanical issue 2
Noise, Audible 2
Port leak(s) 2
Sticking 2
Fracture 2
Failure to auto stop 2
Electrical issue 2
Fail-safe mechanism issue 1
No flow 1
Difficult to open or close 1
Runaway 1
Noise 1
Performance 1
Device contamination with blood or blood product 1
Tear, rip or hole in device packaging 1
Power source issue 1
Material deformation 1
Leak 1
Mechanical jam 1
Temperature issue 1
Fluid leak 1
Crack 1
Difficult to advance 1
Monitor failure 1
Material rupture 1
Total Device Problems 306

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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