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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 42
Device displays error message 38
Device operates differently than expected 30
Ambient noise issue 22
Break 20
Fracture 19
Malfunction 19
No display or display failure 17
Failure to charge 11
Battery issue 11
Device Issue 9
Sensor problems 8
Device stops intermittently 7
Application program issue 7
Alarm, audible 7
Device alarm system issue 7
Incorrect display 7
Electro-magnetic interference (EMI) 6
Computer software issue 6
Failure to pump 6
Noise 5
Unable to obtain readings 5
Failure to power-up 5
Decreased pump speed 5
Restricted flowrate 5
Performance 5
Data Issue 5
Noise, Audible 4
Torn material 4
Connection issue 4
Improper device output 4
Pumping issue 4
Loose or intermittent connection 4
Component(s), broken 4
Crack 4
Loss of power 4
Incorrect or inadequate result 4
Self-activation or keying 4
Material separation 4
Component missing 4
Vibration 3
Application interface becomes non-functional or program exits abnormally 3
Erratic display 3
Detachment of device component 3
No device output 3
Overheating of device or device component 3
Peeled 2
Inaccurate flowrate 2
Material frayed 2
Degraded 2
Failure to Adhere or Bond 2
Invalid sensing 2
Application program version or upgrade problem 2
Charging issue 2
Communication or transmission issue 2
Device inoperable 2
Use of Device Issue 2
Temperature issue 2
Maintenance does not comply to manufacturers recommendations 2
Naturally worn 2
No flow 2
No Known Device Problem 2
Low battery 2
Improper alarm 2
Inadequate lighting 1
Infusion or flow issue 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
Insufficient flow or underinfusion 1
Unstable 1
Smoking 1
Device remains activated 1
Pre or post-pumping problem 1
Cut in material 1
Cable, defective 1
Defective component 1
Out-of-box failure 1
Battery charger, defective 1
Premature discharge of battery 1
False alarm 1
Circuit Failure 1
Burn of device or device component 1
Failure to run on AC/DC 1
Component falling 1
Corrosion 1
Hole in material 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
Total Device Problems 611

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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