TPLC - Total Product Life Cycle

• Device: tubing, pump, cardiopulmonary bypass
• Regulation Description: Cardiopulmonary bypass pump tubing.
• Product Code: DWE
• Regulation Number: 870.4390
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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	20
Disconnection	4
Fluid leak	4
Poor gas exchange	4
Unknown (for use when the device problem is not known)	4
Tube(s), splitting of	3
Restricted flowrate	3
Loose or intermittent connection	2
Misassembled	2
Material rupture	2
Material separation	2
Tears, rips, holes in device, device material	2
Other (for use when an appropriate device code cannot be identified)	1
Decreased pump speed	1
Kinked	1
Occlusion within device	1
Unsealed device packaging	1
Circuit Failure	1
Collapse	1
Detachment of device component	1
Malfunction	1
Device markings issue	1
Improper flow or infusion	1
Inadequate user interface	1
Manufacturing or shipping issue associated with device	1
Total Device Problems	65

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	0	1	2	0	1	0
Class III	2	0	0	0	1	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Maquet Cardiovascular, LLC	III	Mar-16-2011
2	Maquet Inc.	II	Oct-06-2010
3	Maquet Inc.	II	Sep-12-2010
4	Medtronic Cardiovascular Revascularization & Surgical Therap	II	Jun-23-2009
5	Medtronic Inc. Cardiac Rhythm Disease Management	II	Jan-18-2012
6	Medtronic Perfusion Systems	II	Sep-25-2007
7	Medtronic Perfusion Systems	III	Mar-08-2007
8	Medtronic Perfusion Systems	III	Jan-25-2007