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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 3

Device Problems
No display or display failure 94
Device displays error message 91
Pumping stopped 66
Other (for use when an appropriate device code cannot be identified) 35
Failure to pump 32
Device operates differently than expected 26
Break 14
Detachment of device component 8
Device stops intermittently 7
Decreased pump speed 6
Failure to power-up 5
Incorrect display 5
Device Issue 5
Malfunction 5
Failure to auto stop 4
Pumping issue 4
Increased pump speed 4
Suction issue 3
False alarm 3
Loose or intermittent connection 3
Positioning Issue 3
Device markings issue 2
Noise, Audible 2
Mechanical issue 2
Alarm not visible 2
Fracture 2
Image display error 2
Electrical issue 2
Sticking 2
Device alarm system issue 2
Port leak(s) 2
Loss of power 2
Runaway 1
Material rupture 1
Noise 1
Insufficient flow or underinfusion 1
Component missing 1
Device contamination with blood or blood product 1
Fluid leak 1
Use of Incorrect Control Settings 1
Crack 1
Erratic display 1
Leak 1
Monitor failure 1
Overheating of device or device component 1
Performance 1
Temperature issue 1
Power source issue 1
Communication or transmission issue 1
Detachment of device or device component 1
Improper device output 1
Material deformation 1
Mechanical jam 1
No flow 1
Physical resistance 1
Tear, rip or hole in device packaging 1
Difficult to advance 1
Difficult to open or close 1
Fail-safe mechanism issue 1
Total Device Problems 472

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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