TPLC - Total Product Life Cycle

• Device: sensor, blood-gas, in-line, cardiopulmonary bypass
• Regulation Description: Cardiopulmonary bypass in-line blood gas sensor.
• Product Code: DTY
• Regulation Number: 870.4410
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
INTERNATIONAL BIOPHYSICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Device displays error message	59
Device operates differently than expected	39
Failure to power-up	27
Battery issue	24
Fracture	19
Break	18
Device inoperable	14
No display or display failure	13
Communication or transmission issue	11
Calibration issue	9
Failure to calibrate	7
Component missing	6
Charging issue	4
Leak	4
Failure to charge	3
Detachment of device component	3
Unable to obtain readings	3
Incorrect or inadequate result	3
Data Issue	3
No Information	2
Connection issue	2
Material Protrusion	2
Aborted charge	2
Ambient noise issue	2
Loose or intermittent connection	2
Image display error	1
Image orientation incorrect	1
Circuit Failure	1
Device clogged	1
Incorrect display	1
False device output	1
Component falling	1
Corrosion	1
Crack	1
Material disintegration	1
Erratic display	1
Calibration error	1
Failure to run on AC/DC	1
Device alarm system issue	1
Bent	1
Low readings	1
Failure to advance	1
Low battery	1
Device damaged prior to use	1
Failure to sense	1
Material separation	1
Device stops intermittently	1
Output issue	1
Failure of device to self-test	1
Improper device output	1
Material integrity issue	1
Total Device Problems	307

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Terumo Cardiovascular Systems Corporation	II	Apr-11-2011