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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 34
Device operates differently than expected 30
Ambient noise issue 22
Break 20
Fracture 19
Malfunction 19
No display or display failure 15
Failure to charge 11
Battery issue 11
Device Issue 8
Sensor problems 8
Device stops intermittently 7
Application program issue 7
Alarm, audible 7
Device alarm system issue 7
Computer software issue 6
Incorrect display 6
Electro-magnetic interference (EMI) 6
Failure to pump 6
Unable to obtain readings 5
Failure to power-up 5
Decreased pump speed 5
Noise 5
Restricted flowrate 5
Performance 5
Data Issue 5
Torn material 4
Pumping issue 4
Improper device output 4
Loose or intermittent connection 4
Component(s), broken 4
Crack 4
Self-activation or keying 4
Material separation 4
Loss of power 4
Connection issue 4
Component missing 4
Vibration 3
Incorrect or inadequate result 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
Noise, Audible 3
Improper alarm 2
Maintenance does not comply to manufacturers recommendations 2
Naturally worn 2
No flow 2
Peeled 2
Inaccurate flowrate 2
Material frayed 2
Degraded 2
Failure to Adhere or Bond 2
Device inoperable 2
Use of Device Issue 2
Low battery 2
Charging issue 2
Communication or transmission issue 2
Application program version or upgrade problem 2
Cut in material 1
Out-of-box failure 1
Invalid sensing 1
Cable, defective 1
Insufficient flow or underinfusion 1
Unstable 1
Smoking 1
Device remains activated 1
Pre or post-pumping problem 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
No Known Device Problem 1
Output issue 1
Positioning Issue 1
Power source issue 1
Protective measure issue 1
Inadequate lighting 1
Infusion or flow issue 1
Device sensing issue 1
Difficult to open or close 1
Material integrity issue 1
Temperature issue 1
Total Device Problems 596

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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