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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 110
Device displays error message 104
Pumping stopped 73
Failure to pump 38
Other (for use when an appropriate device code cannot be identified) 35
Device operates differently than expected 26
Break 14
Detachment of device component 8
Device stops intermittently 7
Decreased pump speed 6
Incorrect display 6
Failure to power-up 5
Device Issue 5
Malfunction 5
Failure to auto stop 4
Pumping issue 4
Increased pump speed 4
False alarm 4
Loose or intermittent connection 3
Loss of power 3
Suction issue 3
Positioning Issue 3
Mechanical jam 2
Noise, Audible 2
Sticking 2
Device markings issue 2
Port leak(s) 2
Fracture 2
Image display error 2
Mechanical issue 2
Electrical issue 2
Device alarm system issue 2
Alarm not visible 2
Defective Alarm 1
Use of Incorrect Control Settings 1
Crack 1
Erratic display 1
Fluid leak 1
Monitor failure 1
Overheating of device or device component 1
Performance 1
Leak 1
Insufficient flow or underinfusion 1
Component missing 1
Device contamination with blood or blood product 1
Noise 1
Runaway 1
Material rupture 1
Communication or transmission issue 1
Detachment of device or device component 1
Physical resistance 1
Tear, rip or hole in device packaging 1
Failure to shut off 1
Improper device output 1
Material deformation 1
Difficult to advance 1
Difficult to open or close 1
Fail-safe mechanism issue 1
Temperature issue 1
No flow 1
Power source issue 1
Total Device Problems 520

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 2 0 0 0 0 0 0
Class III 0 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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