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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 190
Device displays error message 169
Pumping stopped 106
Failure to pump 46
Other (for use when an appropriate device code cannot be identified) 35
Device operates differently than expected 29
Break 15
Detachment of device component 11
Pumping issue 9
Incorrect display 8
Failure to power-up 8
Failure to auto stop 7
Device stops intermittently 7
Device Issue 6
Decreased pump speed 6
Malfunction 5
Positioning Issue 4
Increased pump speed 4
False alarm 4
Device alarm system issue 3
Crack 3
Image display error 3
Loss of power 3
Loose or intermittent connection 3
Mechanical issue 3
Detachment of device or device component 3
Suction issue 3
Insufficient flow or underinfusion 2
Sticking 2
Device markings issue 2
Power source issue 2
Protective measure issue 2
Mechanical jam 2
No flow 2
Infusion or flow issue 2
Overheating of device or device component 2
Port leak(s) 2
Fracture 2
Electrical issue 2
Alarm not visible 2
Noise, Audible 2
Temperature issue 1
Defective Alarm 1
Not audible alarm 1
Use of Incorrect Control Settings 1
Burn of device or device component 1
Fluid leak 1
Leak 1
Erratic display 1
Decrease in pressure 1
Runaway 1
Material rupture 1
Difficult to position 1
Performance 1
Moisture damage 1
Monitor failure 1
Material deformation 1
Failure to shut off 1
Improper device output 1
Physical resistance 1
Device sensing issue 1
Difficult to advance 1
Difficult to open or close 1
Fail-safe mechanism issue 1
Device inoperable 1
Unstable 1
Volume accuracy issue 1
Noise 1
Tear, rip or hole in device packaging 1
Component missing 1
Device contamination with blood or blood product 1
Calibration issue 1
Communication or transmission issue 1
Connection issue 1
Total Device Problems 754

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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