TPLC - Total Product Life Cycle

• Device: ventricular (assisst) bypass
• Definition: Approved pma: P870072
• Product Code: DSQ
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017
7	5	9	12	4	20	36	30	24	37	9

Device Problems
No Known Device Problem	5837
Other (for use when an appropriate device code cannot be identified)	4637
Battery issue	2252
Device stops intermittently	1426
Connection issue	1424
Loose or intermittent connection	1059
Power source issue	992
Infusion or flow issue	885
Pumping issue	792
High Readings	712
Break	675
Device operates differently than expected	475
Decreased pump speed	461
Obstruction within device	342
Pumping stopped	321
Foreign material present in device	301
Electrical shorting	276
Device alarm system issue	235
No Information	211
Not audible alarm	191
Use of Device Issue	161
Device displays error message	139
Disconnection	139
Contamination during use	127
Loss of power	119
Malposition of device	118
No display or display failure	100
Overheating of device or device component	98
Blockage within device or device component	91
Communication or transmission issue	85
Occlusion within device	80
Electrical issue	80
Image display error	69
Maintenance does not comply to manufacturers recommendations	68
Material integrity issue	62
Output issue	60
Increased pump speed	58
Material deformation	57
Protective measure issue	55
Kinked	55
Bent	54
Malfunction	52
Torn material	52
Cut in material	51
Device Issue	47
Low audible alarm	47
Restricted flowrate	46
Premature discharge of battery	41
Detachment of device component	38
Migration of device or device component	38
Noise, Audible	37
Data Issue	33
Improper flow or infusion	33
Circuit Failure	33
Failure to power-up	33
Leak	29
Device inoperable	27
Vibration	25
Air leak	22
Naturally worn	21
Failure to pump	20
Alarm not visible	19
Poor quality image	18
Low readings	18
Fracture	17
Hole in material	16
Low battery	15
No code available	14
Temperature issue	13
Dislodged or dislocated	13
Device or device component damaged by another device	13
Incorrect display	12
Crack	12
Mechanical issue	10
Improper or incorrect procedure or method	10
Insufficient flow or underinfusion	9
Difficult to open or close	9
Human-Device Interface Issue	9
Issue with displayed error message	9
Material twisted	9
No flow	8
Detachment of device or device component	8
Patient-device incompatibility	8
Material separation	8
Failure to charge	8
Particulates	7
Electro-static discharge	7
Increase in suction	7
Date-related software issue	7
Improper alarm	7
Device handling issue	6
Charging issue	6
Fitting problem	6
Power Conditioning Issue	6
Moisture damage	6
Degraded	5
False alarm	5
Smoking	5
Problem with software installation	5
Positioning Issue	4
Total Device Problems	26478

Recalls
	2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017
Class I	3	0	0	1	0	1	0	2	5	3	3
Class II	2	1	3	1	0	0	3	1	2	0	0
Class III	0	0	0	0	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Abiomed, Inc.	I	Mar-04-2010
2	Abiomed, Inc.	II	Sep-16-2009
3	Abiomed, Inc.	II	Sep-01-2009
4	Abiomed, Inc.	II	Mar-07-2007
5	Carestream Health Inc.	II	Nov-13-2013
6	HeartWare Inc	I	Oct-17-2016
7	HeartWare Inc	I	Jul-08-2016
8	HeartWare Inc	II	Jun-26-2015
9	HeartWare Inc	I	Jun-13-2015
10	HeartWare Inc	I	Jun-11-2015
11	HeartWare Inc	II	Jun-10-2015
12	HeartWare Inc	I	Jun-08-2015
13	HeartWare Inc	I	May-14-2015
14	HeartWare Inc	I	Feb-25-2015
15	HeartWare Inc	II	May-14-2014
16	HeartWare Inc	I	Apr-23-2014
17	HeartWare Inc	II	Jul-29-2013
18	HeartWare, Inc	I	Oct-13-2016
19	Heartware	I	Apr-27-2017
20	Heartware	I	Apr-25-2017
21	Heartware Inc	II	May-14-2013
22	Thoratec Corp	II	Nov-24-2009
23	Thoratec Corp	II	Dec-22-2008
24	Thoratec Corp	I	Nov-21-2007
25	Thoratec Corp	I	Jul-27-2007
26	Thoratec Corp	I	Jul-27-2007
27	Thoratec Corp	II	Feb-10-2007
28	Thoratec Corp	II	Oct-13-2010
29	Thoratec Corporation	I	May-24-2017
30	Thoratec Corporation	I	Mar-21-2014
31	Thoratec Corporation	I	Mar-23-2012