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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tubing, pump, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass pump tubing.
Product CodeDWE
Regulation Number 870.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COBE INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Leak 76
Fluid leak 47
Device operates differently than expected 21
Filtration issue 14
Improper flow or infusion 13
Misassembled 10
Device misassembled during manufacturing or shipping 7
Malfunction 6
Kinked 6
Loose or intermittent connection 6
Infusion or flow issue 5
Packaging issue 5
Unknown (for use when the device problem is not known) 4
Restricted flowrate 4
Detachment of device component 4
Disconnection 4
Poor gas exchange 4
Tube(s), splitting of 4
Use of Device Issue 4
Improper or incorrect procedure or method 3
Other (for use when an appropriate device code cannot be identified) 3
Crack 3
Device markings issue 3
Blocked connection 3
Connection issue 2
Labeling, missing 2
Unsealed device packaging 2
Device displays error message 2
Occlusion within device 2
Pressure issue 2
Pumping issue 2
Manufacturing or shipping issue associated with device 2
Foreign material present in device 2
Air leak 2
Component(s), broken 2
Material rupture 2
Material separation 2
Shipping damage or problem 2
Tears, rips, holes in device, device material 2
User used incorrect product for intended use 2
Decreased pump speed 1
Failure to analyze rhythm 1
Laser pulse timing error 1
Misconnection 1
Delivered as unsterile product 1
Fracture 1
Incorrect measurement 1
Migration of device or device component 1
Loss of or failure to bond 1
Break 1
Circuit Failure 1
Collapse 1
Decoupling 1
False device output 1
Free or unrestricted flow 1
Improper device output 1
Inadequate user interface 1
Device sensing issue 1
Mechanics altered 1
No flow 1
No Known Device Problem 1
Output issue 1
Not Applicable 1
No code available 1
No device output 1
Obstruction within device 1
Device damaged prior to use 1
Defective component 1
Component missing 1
Device contamination with blood or blood product 1
Tear, rip or hole in device packaging 1
Defective item 1
Total Device Problems 323

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 1 0 1 2 0 1 1 1 1 2
Class III 2 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II May-20-2016
2 Datascope Corporation II Jun-15-2016
3 Maquet Cardiovascular, LLC III Mar-16-2011
4 Maquet Inc. II Oct-06-2010
5 Maquet Inc. II Sep-12-2010
6 Medtronic Cardiovascular Revascularization & Surgical Therap II Jun-23-2009
7 Medtronic Inc. Cardiac Rhythm Disease Management II Feb-20-2014
8 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-27-2013
9 Medtronic Inc. Cardiac Rhythm Disease Management II Jan-18-2012
10 Medtronic Perfusion Systems II Sep-04-2015
11 Medtronic Perfusion Systems II Sep-25-2007
12 Medtronic Perfusion Systems III Mar-08-2007
13 Medtronic Perfusion Systems III Jan-25-2007

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