TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2015	2016	2017	2018	2019	2020
24	37	36	35	34	30

Device Problems
Adverse Event Without Identified Device or Use Problem	27030
Battery Problem	5130
Power Problem	4776
Pumping Problem	3895
Connection Problem	2984
Break	2870
Infusion or Flow Problem	1896
Pumping Stopped	1798
Device Stops Intermittently	1757
Material Integrity Problem	1349
Loose or Intermittent Connection	1274
Obstruction of Flow	1226
High Readings	1128
Decreased Pump Speed	749
Mechanical Problem	641
Material Twisted / Bent	576
Controller	548
Material Deformation	521
Disconnection	483
Electrical /Electronic Property Problem	456
Insufficient Information	441
Device Displays Incorrect Message	418
Material Split, Cut or Torn	418
Use of Device Problem	374
Electrical Shorting	325
Device Contamination with Chemical or Other Material	310
Device Alarm System	276
Complete Loss of power	268
No Audible Alarm	262
Battery	261
Loss of Power	256
Malposition of device	247
Partial Blockage	238
Electrical Power Problem	217
Device Operates Differently Than Expected	204
Communication or Transmission Problem	204
Naturally Worn	200
Appropriate Term/Code Not Available	198
Restricted Flow rate	181
Output Problem	180
Contamination During Use	176
Protective Measures Problem	176
Overheating of Device	172
Pump	172
No Display / Image	146
Data Problem	124
Device Inoperable	118
Date/Time-Related Software Problem	116
Increase in Suction	116
Noise, Audible	112
Leak / Splash	102
Kinked	93
Maintenance Does Not Comply To Manufacturers Recommendations	85
Torn Material	81
Bent	80
Display or Visual Feedback Problem	78
Crack	73
Image Display Error / Artifact	72
Low Readings	66
Low Audible Alarm	63
Cut In Material	63
Increased Pump Speed	60
Migration or Expulsion of Device	55
Cable	53
Insufficient Flow or Under Infusion	50
Failure to Pump	49
Occlusion Within Device	49
Device Difficult to Setup or Prepare	45
Incomplete or Inadequate Connection	44
Vibration	44
Improper Flow or Infusion	38
Detachment of Device or device Component	36
Circuit Failure	33
Detachment Of Device Component	30
Material Separation	29
Alarm	29
Device Damaged Prior to Use	28
Fluid Leak	28
Poor Quality Image	27
Deformation Due to Compressive Stress	26
Fitting Problem	24
Improper or Incorrect Procedure or Method	23
Fracture	23
Difficult to Remove	22
Alarm Not Visible	22
Electromagnetic Interference	22
Device Misassembled During Manufacturing / Shipping	21
Moisture Damage	20
Device Issue	20
Device Fell	20
Failure to Power Up	20
Connector Pin	19
Material Protrusion / Extrusion	19
Particulates	18
Failure to Charge	18
Hole In Material	17
Material Discolored	17
Temperature Problem	17
Electro-Static Discharge	17
Connector	17
Total Device Problems	69998

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott	I	May-17-2018
2	HeartWare Inc	II	Jun-26-2015
3	HeartWare Inc	I	Jun-13-2015
4	HeartWare Inc	I	Jun-11-2015
5	HeartWare Inc	II	Jun-10-2015
6	HeartWare Inc	I	Jun-08-2015
7	HeartWare Inc	I	May-14-2015
8	HeartWare Inc	I	Feb-25-2015
9	HeartWare, Inc	I	Oct-13-2016
10	Heartware	I	May-21-2018
11	Heartware	I	Apr-27-2017
12	Heartware	I	Apr-25-2017
13	Heartware, Inc.	I	May-22-2020
14	Heartware, Inc.	I	Mar-09-2020
15	Heartware, Inc.	II	Dec-07-2018
16	Heartware, Inc.	II	Oct-03-2018
17	Heartware, Inc.	I	Oct-17-2016
18	Heartware, Inc.	I	Jul-08-2016
19	Jarvik Heart Inc	II	Dec-18-2018
20	Thoratec Corp.	II	Dec-27-2019
21	Thoratec Corp.	II	Aug-22-2019
22	Thoratec Corp.	II	Apr-19-2019
23	Thoratec Corporation	I	May-24-2017