• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 46
Device displays error message 40
Device operates differently than expected 31
Ambient noise issue 22
No display or display failure 22
Break 20
Fracture 19
Malfunction 19
Failure to charge 11
Battery issue 11
Device Issue 9
Device stops intermittently 9
Sensor problems 8
Device alarm system issue 8
Alarm, audible 7
Incorrect display 7
Application program issue 7
Incorrect or inadequate result 6
Failure to pump 6
Failure to power-up 6
Electro-magnetic interference (EMI) 6
Computer software issue 6
Restricted flowrate 5
Performance 5
Unable to obtain readings 5
Decreased pump speed 5
Noise 5
Data Issue 5
Noise, Audible 4
Torn material 4
Pumping issue 4
Connection issue 4
Improper device output 4
Infusion or flow issue 4
No flow 4
Component missing 4
Loss of power 4
Self-activation or keying 4
Material separation 4
No device output 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
Overheating of device or device component 3
Erratic display 3
Vibration 3
Application program version or upgrade problem 2
Invalid sensing 2
Insufficient flow or underinfusion 2
Smoking 2
Use of Device Issue 2
Device inoperable 2
Peeled 2
Inaccurate flowrate 2
Material frayed 2
Degraded 2
Failure to Adhere or Bond 2
No Known Device Problem 2
Maintenance does not comply to manufacturers recommendations 2
Improper flow or infusion 2
Low battery 2
Charging issue 2
Communication or transmission issue 2
Temperature issue 2
Improper alarm 2
Naturally worn 2
Device sensing issue 1
Difficult to open or close 1
Dislodged or dislocated 1
Inadequate lighting 1
Material integrity issue 1
No Pressure 1
Output issue 1
Positioning Issue 1
Power source issue 1
Protective measure issue 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
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
Unstable 1
Failure to sense 1
Pre or post-pumping problem 1
Increased pump speed 1
Device remains activated 1
Total Device Problems 639

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

-
-