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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
Unable to obtain readings 6
Loose or intermittent connection 6
Loss of power 5
Device alarm system issue 5
Circuit Failure 4
Incorrect display 4
Pumping stopped 4
No Known Device Problem 4
Device sensing issue 3
Difficult to advance 3
Peeled 3
Degraded 3
Erratic display 3
Mechanical jam 3
Power source issue 2
Failure to run on AC/DC 2
Electrical issue 2
Corrosion 2
False alarm 2
Hole in material 2
Leak 2
Device Difficult to Setup or Prepare 2
Difficult to open or close 2
Electrical shorting 2
Device markings issue 2
Application program issue 2
Defective component 2
Cut in material 2
Sticking 2
Device stops intermittently 1
Volume accuracy issue 1
Fitting problem 1
Failure to sense 1
Shelf life exceeded 1
Out-of-box failure 1
Failure to calibrate 1
Connection issue 1
Delamination 1
Detachment of device or device component 1
Calibration issue 1
Charging issue 1
Output issue 1
No flow 1
Failure to shut off 1
Foreign material present in device 1
Inadequate lighting 1
Material deformation 1
Material integrity issue 1
Material Protrusion 1
Increased pump speed 1
Failure to pump 1
Image orientation incorrect 1
Performance 1
Migration of device or device component 1
Monitor failure 1
Occlusion within device 1
No device output 1
Defective Alarm 1
Calibration error 1
Failure to charge 1
Crack 1
Intermittent continuity 1
Grounding malfunction 1
Failure to deploy 1
Problem with software installation 1
Reset issue 1
Scratched material 1
Torn material 1
Data Issue 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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