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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device generator, pulsatile flow, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass pulsatile flow generator.
Definition Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary bypass pulsatile flow generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Product CodeJOR
Regulation Number 870.4320
Device Class 3

Device Problems
Device operates differently than expected 78
Ambient noise issue 44
Fracture 33
Break 32
No display or display failure 29
Device displays error message 25
Battery issue 24
Pumping issue 12
Component missing 11
Naturally worn 9
Failure to power-up 8
Incorrect or inadequate result 7
Communication or transmission issue 7
Loose or intermittent connection 6
Unable to obtain readings 6
Device alarm system issue 5
Loss of power 5
Pumping stopped 4
Incorrect display 4
Circuit Failure 4
No Known Device Problem 4
Degraded 3
Device sensing issue 3
Erratic display 3
Difficult to advance 3
Mechanical jam 3
Peeled 3
Sticking 2
Electrical shorting 2
Leak 2
Application program issue 2
Hole in material 2
Device markings issue 2
Failure to run on AC/DC 2
Cut in material 2
Defective component 2
Power source issue 2
False alarm 2
Corrosion 2
Difficult to open or close 2
Device Difficult to Setup or Prepare 2
Electrical issue 2
Occlusion within device 1
Connection issue 1
Intermittent continuity 1
Failure to pump 1
Failure to calibrate 1
Delamination 1
Failure to charge 1
Inadequate lighting 1
No flow 1
Performance 1
Device stops intermittently 1
Data Issue 1
Material integrity issue 1
Charging issue 1
Migration of device or device component 1
Failure to sense 1
Problem with software installation 1
Calibration issue 1
Detachment of device or device component 1
Failure to shut off 1
Shelf life exceeded 1
No device output 1
Increased pump speed 1
Crack 1
Output issue 1
Torn material 1
Defective Alarm 1
Calibration error 1
Grounding malfunction 1
Image orientation incorrect 1
Monitor failure 1
Volume accuracy issue 1
Scratched material 1
Out-of-box failure 1
Failure to deploy 1
Material Protrusion 1
Foreign material present in device 1
Material deformation 1
Reset issue 1
Fitting problem 1
Total Device Problems 445

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 1 0 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 Dec-08-2010

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