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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 50
Device displays error message 41
Device operates differently than expected 33
No display or display failure 25
Ambient noise issue 22
Break 20
Fracture 19
Malfunction 19
Device stops intermittently 14
Failure to charge 11
Battery issue 11
Incorrect or inadequate result 10
Device Issue 9
Sensor problems 8
Device alarm system issue 8
Alarm, audible 7
Incorrect display 7
Application program issue 7
Failure to pump 6
Loss of power 6
Failure to power-up 6
Electro-magnetic interference (EMI) 6
Computer software issue 6
Restricted flowrate 5
Performance 5
Decreased pump speed 5
Unable to obtain readings 5
Noise 5
Infusion or flow issue 5
No flow 5
Pumping issue 5
Data Issue 5
Noise, Audible 4
Torn material 4
Maintenance does not comply to manufacturers recommendations 4
Improper device output 4
Connection issue 4
Invalid sensing 4
Component missing 4
Material separation 4
Self-activation or keying 4
No device output 4
Overheating of device or device component 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
Vibration 3
Erratic display 3
Use of Device Issue 2
Device inoperable 2
Smoking 2
Insufficient flow or underinfusion 2
Application program version or upgrade problem 2
Low battery 2
Degraded 2
Failure to Adhere or Bond 2
Peeled 2
Inaccurate flowrate 2
Material frayed 2
Improper alarm 2
Charging issue 2
Communication or transmission issue 2
Improper flow or infusion 2
Output issue 2
Positioning Issue 2
Naturally worn 2
Temperature issue 2
No Known Device Problem 2
No Pressure 1
Power source issue 1
Protective measure issue 1
Inadequate lighting 1
Material integrity issue 1
Device sensing issue 1
Difficult to open or close 1
Dislodged or dislocated 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
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
Cut in material 1
Defective component 1
Out-of-box failure 1
Cable, defective 1
Failure to sense 1
Total Device Problems 670

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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