TPLC - Total Product Life Cycle

• Device: controller, temperature, cardiopulmonary bypass
• Regulation Description: Cardiopulmonary bypass temperature controller.
• Product Code: DWC
• Regulation Number: 870.4250
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CINCINNATI SUB-ZERO PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GAMBRO
	SUBSTANTIALLY EQUIVALENT	2
JOSTRA
	SUBSTANTIALLY EQUIVALENT	2
MINNTECH
	SUBSTANTIALLY EQUIVALENT	1
ORIGEN BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SEABROOK MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHILEY, INC
	SUBSTANTIALLY EQUIVALENT	1
SORIN
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device operates differently than expected	99
Insufficient heating	61
Device displays error message	45
Ambient noise issue	37
Leak	35
Component missing	19
Device alarm system issue	18
Fracture	18
Temperature issue	17
Torn material	13
Infusion or flow issue	13
Insufficient cooling	12
Failure to pump	11
Break	10
Device stops intermittently	10
Incorrect or inadequate result	8
Failure to power-up	7
Material discolored	6
Material Distortion	5
Corrosion	4
Crack	4
Calibration issue	4
Naturally worn	4
No flow	4
Material deformation	3
Improper flow or infusion	3
Overfill	3
Failure to sense	3
Erratic display	3
No display or display failure	3
Grounding malfunction	3
Material erosion	3
Overheating of device or device component	3
Material torqued	3
Hole in material	2
Loose or intermittent connection	2
Inaccurate flowrate	2
Fluid leak	2
Smoking	2
Other (for use when an appropriate device code cannot be identified)	2
Device inoperable	2
Connection issue	2
Inappropriate or unexpected reset	2
Free or unrestricted flow	2
Device sensing issue	2
Difficult to open or close	2
Electrical shorting	1
Failure of device to self-test	1
Improper device output	1
Device or device component damaged by another device	1
Output issue	1
Pumping issue	1
Reset issue	1
Dent in material	1
Fumes or vapors	1
Device Issue	1
Valve(s), sticking	1
Insufficient flow or underinfusion	1
Air leak	1
Incorrect display	1
Failure to deploy	1
Device clogged	1
Cool, failure to	1
Alarm not visible	1
Mechanical issue	1
Device emits odor	1
Output above specifications	1
Excess flow or overinfusion	1
Peeled	1
Loss of power	1
Decreased pump speed	1
Increased pump speed	1
Material rupture	1
Sensing intermittently	1
Pumping stopped	1
Material puncture	1
Unable to obtain readings	1
Data Issue	1
Total Device Problems	550

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

Recalls
Manufacturer		Recall Class	Date Posted
1	MAQUET Inc.	II	Jan-25-2007
2	Terumo Cardiovascular Systems Corporation	II	Nov-13-2012