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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 125
Device displays error message 120
Pumping stopped 85
Failure to pump 40
Other (for use when an appropriate device code cannot be identified) 35
Device operates differently than expected 26
Break 15
Detachment of device component 8
Device stops intermittently 7
Decreased pump speed 6
Incorrect display 6
Failure to auto stop 6
Device Issue 5
Malfunction 5
Pumping issue 5
Failure to power-up 5
Increased pump speed 4
False alarm 4
Device alarm system issue 3
Image display error 3
Loose or intermittent connection 3
Mechanical issue 3
Suction issue 3
Loss of power 3
Detachment of device or device component 3
Positioning Issue 3
Sticking 2
Protective measure issue 2
Device markings issue 2
Mechanical jam 2
Noise, Audible 2
Overheating of device or device component 2
Fracture 2
Port leak(s) 2
Electrical 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
Leak 1
Performance 1
Decrease in pressure 1
Runaway 1
Material rupture 1
Insufficient flow or underinfusion 1
Unstable 1
Noise 1
Temperature issue 1
No flow 1
Power source issue 1
Physical resistance 1
Communication or transmission issue 1
Connection issue 1
Tear, rip or hole in device packaging 1
Component missing 1
Device contamination with blood or blood product 1
Failure to shut off 1
Improper device output 1
Infusion or flow issue 1
Material deformation 1
Difficult to advance 1
Difficult to open or close 1
Fail-safe mechanism issue 1
Total Device Problems 581

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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