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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 49
Device displays error message 41
Device operates differently than expected 33
No display or display failure 25
Ambient noise issue 22
Break 20
Malfunction 19
Fracture 19
Device stops intermittently 12
Battery issue 11
Failure to charge 11
Device Issue 9
Sensor problems 8
Device alarm system issue 8
Incorrect display 7
Application program issue 7
Alarm, audible 7
Failure to pump 6
Electro-magnetic interference (EMI) 6
Failure to power-up 6
Incorrect or inadequate result 6
Computer software issue 6
Unable to obtain readings 5
Restricted flowrate 5
Decreased pump speed 5
Noise 5
Data Issue 5
Performance 5
Improper device output 4
Infusion or flow issue 4
No flow 4
Maintenance does not comply to manufacturers recommendations 4
Component missing 4
Invalid sensing 4
Connection issue 4
Self-activation or keying 4
Loose or intermittent connection 4
No device output 4
Torn material 4
Component(s), broken 4
Noise, Audible 4
Crack 4
Pumping issue 4
Material separation 4
Loss of power 4
Detachment of device component 3
Overheating of device or device component 3
Erratic display 3
Application interface becomes non-functional or program exits abnormally 3
Vibration 3
Device inoperable 2
Failure to Adhere or Bond 2
Charging issue 2
Inaccurate flowrate 2
Application program version or upgrade problem 2
Communication or transmission issue 2
Material frayed 2
No Known Device Problem 2
Use of Device Issue 2
Smoking 2
Degraded 2
Insufficient flow or underinfusion 2
Low battery 2
Temperature issue 2
Naturally worn 2
Improper flow or infusion 2
Improper alarm 2
Peeled 2
No Pressure 1
Device maintenance issue 1
Battery charger, defective 1
Protective measure issue 1
Hole in material 1
Out-of-box failure 1
Output issue 1
Failure to run on AC/DC 1
Nonstandard device or device component 1
Cut in material 1
Increased pump speed 1
Difficult to position 1
Material erosion 1
Positioning Issue 1
Burn of device or device component 1
Component falling 1
Dislodged or dislocated 1
Difficult to open or close 1
Inadequate lighting 1
Electrical issue 1
Device remains activated 1
Failure to run on portable mode 1
Cable, defective 1
Premature discharge of battery 1
Circuit Failure 1
Motor drive unit (MDU) stalled or jammed 1
Failure to sense 1
Pre or post-pumping problem 1
Material integrity issue 1
Unstable 1
Corrosion 1
Total Device Problems 655

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 1 0 2 0 1 0 0 0
Class III 0 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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