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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 57
Device displays error message 49
Device operates differently than expected 35
No display or display failure 33
Ambient noise issue 22
Break 21
Fracture 19
Device stops intermittently 19
Malfunction 19
Incorrect or inadequate result 15
Failure to charge 12
Battery issue 11
Device Issue 9
Sensor problems 8
Loss of power 8
Device alarm system issue 8
No flow 8
Infusion or flow issue 7
Alarm, audible 7
Incorrect display 7
Failure to pump 7
Application program issue 7
Failure to power-up 6
Electro-magnetic interference (EMI) 6
Computer software issue 6
Restricted flowrate 5
No device output 5
Overheating of device or device component 5
Performance 5
Decreased pump speed 5
Unable to obtain readings 5
Noise 5
Improper device output 5
Pumping issue 5
Data Issue 5
Noise, Audible 4
Torn material 4
Connection issue 4
Maintenance does not comply to manufacturers recommendations 4
Invalid sensing 4
Component missing 4
Self-activation or keying 4
Material separation 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
Erratic display 3
Vibration 3
Low battery 3
Power source issue 3
No Known Device Problem 3
Output issue 3
Positioning Issue 2
Temperature issue 2
Improper flow or infusion 2
Improper alarm 2
Naturally worn 2
Charging issue 2
Communication or transmission issue 2
Insufficient flow or underinfusion 2
Use of Device Issue 2
Application program version or upgrade problem 2
Smoking 2
Device inoperable 2
Degraded 2
Burn of device or device component 2
Failure to Adhere or Bond 2
Peeled 2
Inaccurate flowrate 2
Electrical issue 2
Material frayed 2
Hole in material 1
Image display error 1
Material erosion 1
Device maintenance issue 1
Motor drive unit (MDU) stalled or jammed 1
Nonstandard device or device component 1
Battery charger, defective 1
Premature discharge of battery 1
Failure to run on AC/DC 1
False alarm 1
Corrosion 1
Component falling 1
Circuit Failure 1
Unstable 1
Failure to sense 1
Device remains activated 1
Increased pump speed 1
Failure to run on portable mode 1
Difficult to position 1
Pre or post-pumping problem 1
Out-of-box failure 1
Electro-static discharge 1
Cable, defective 1
Defective component 1
Cut in material 1
Incorrect or inadequate test results 1
Total Device Problems 725

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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