• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 71
No display or display failure 65
Pumping stopped 52
Other (for use when an appropriate device code cannot be identified) 33
Device operates differently than expected 26
Failure to pump 24
Break 14
Device stops intermittently 7
Device Issue 5
Malfunction 5
Decreased pump speed 4
Increased pump speed 4
Incorrect display 4
Failure to auto stop 4
Pumping issue 4
Positioning Issue 3
False alarm 3
Loose or intermittent connection 3
Failure to power-up 3
Suction issue 3
Device alarm system issue 2
Sticking 2
Mechanical issue 2
Fracture 2
Port leak(s) 2
Alarm not visible 2
Detachment of device component 2
Electrical issue 2
Device markings issue 2
Noise, Audible 2
Temperature issue 1
Power source issue 1
Material deformation 1
Mechanical jam 1
No flow 1
Difficult to advance 1
Difficult to open or close 1
Fail-safe mechanism issue 1
Fluid leak 1
Crack 1
Loss of power 1
Leak 1
Monitor failure 1
Performance 1
Runaway 1
Material rupture 1
Tear, rip or hole in device packaging 1
Noise 1
Component missing 1
Device contamination with blood or blood product 1
Total Device Problems 377

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

-
-