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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device control, pump speed, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass pump speed control.
Product CodeDWA
Regulation Number 870.4380
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC ASSIST DIV.
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
LEVITRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 11
SORIN
  SUBSTANTIALLY EQUIVALENT 3
STOCKERT GMBH
  SUBSTANTIALLY EQUIVALENT 3
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 137
Pumping stopped 45
Device displays error message 39
Device operates differently than expected 30
Ambient noise issue 22
Break 20
No display or display failure 19
Fracture 19
Malfunction 19
Failure to charge 11
Battery issue 11
Device Issue 9
Device stops intermittently 9
Sensor problems 8
Device alarm system issue 8
Alarm, audible 7
Incorrect display 7
Application program issue 7
Failure to pump 6
Electro-magnetic interference (EMI) 6
Computer software issue 6
Restricted flowrate 5
Performance 5
Decreased pump speed 5
Unable to obtain readings 5
Failure to power-up 5
Noise 5
Data Issue 5
Noise, Audible 4
Pumping issue 4
Torn material 4
Connection issue 4
Improper device output 4
Component missing 4
Loss of power 4
Material separation 4
Incorrect or inadequate result 4
Self-activation or keying 4
Loose or intermittent connection 4
Crack 4
Component(s), broken 4
Detachment of device component 3
Application interface becomes non-functional or program exits abnormally 3
No device output 3
Overheating of device or device component 3
Vibration 3
Erratic display 3
Infusion or flow issue 3
Maintenance does not comply to manufacturers recommendations 2
Naturally worn 2
No flow 2
No Known Device Problem 2
Improper alarm 2
Charging issue 2
Communication or transmission issue 2
Temperature issue 2
Use of Device Issue 2
Device inoperable 2
Smoking 2
Invalid sensing 2
Insufficient flow or underinfusion 2
Application program version or upgrade problem 2
Low battery 2
Peeled 2
Inaccurate flowrate 2
Material frayed 2
Degraded 2
Failure to Adhere or Bond 2
Battery charger, defective 1
Premature discharge of battery 1
Burn of device or device component 1
Failure to run on AC/DC 1
False alarm 1
Corrosion 1
Component falling 1
Circuit Failure 1
Hole in material 1
Electrical issue 1
Material erosion 1
Failure to run on portable mode 1
Difficult to position 1
Device maintenance issue 1
Motor drive unit (MDU) stalled or jammed 1
Nonstandard device or device component 1
Cut in material 1
Defective component 1
Cable, defective 1
Out-of-box failure 1
Unstable 1
Pre or post-pumping problem 1
Device remains activated 1
Device sensing issue 1
Difficult to open or close 1
Dislodged or dislocated 1
Output issue 1
Positioning Issue 1
Power source issue 1
Protective measure issue 1
Material integrity issue 1
Inadequate lighting 1
Total Device Problems 625

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 2 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Cardiovascular Revascularization & Surgical Therap II Jun-30-2010
2 Sorin Group Deutschland GmbH II Jan-28-2014
3 Sorin Group Deutschland GmbH II Mar-29-2012
4 Sorin Group USA, Inc. II Oct-29-2012

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