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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventricular (assist) bypass
Definition Approved pma: P870072
Product CodeDSQ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
9 12 4 20 36 30 24 37 36 35 34 48 38 33 48 41

MDR Year MDR Reports MDR Events
2014 3900 3900
2015 6769 6769
2016 7187 7187
2017 9055 9055
2018 12660 12660
2019 20216 20216
2020 14238 14238
2021 15765 15765
2022 15994 15994
2023 13056 13056
2024 9699 9699

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 64587 64587
Battery Problem 9626 9626
Pumping Problem 8434 8434
Power Problem 6581 6581
Mechanical Problem 6315 6315
Infusion or Flow Problem 5776 5776
Pumping Stopped 4102 4102
Break 3940 3940
Connection Problem 3790 3790
Material Integrity Problem 2525 2525
Device Stops Intermittently 2301 2301
Disconnection 2076 2076
Electrical Power Problem 2062 2062
Insufficient Information 1933 1933
Obstruction of Flow 1885 1885
Complete Loss of Power 1857 1857
Electrical /Electronic Property Problem 1836 1836
Decreased Pump Speed 1641 1641
Loose or Intermittent Connection 1383 1383
Material Twisted/Bent 1372 1372
High Readings 1357 1357
Material Deformation 1011 1011
Material Split, Cut or Torn 1004 1004
Use of Device Problem 913 913
No Apparent Adverse Event 893 893
Display or Visual Feedback Problem 849 849
Communication or Transmission Problem 796 796
Device Displays Incorrect Message 688 688
Device Difficult to Setup or Prepare 589 589
Device Alarm System 562 562
Premature Discharge of Battery 528 528
Improper or Incorrect Procedure or Method 502 502
Noise, Audible 497 497
No Audible Alarm 471 471
Loss of Power 454 454
Malposition of Device 451 451
Overheating of Device 415 415
Device Operates Differently Than Expected 404 404
Electrical Shorting 401 401
Device Contamination with Chemical or Other Material 392 392
Increase in Suction 335 335
Appropriate Term/Code Not Available 318 318
Output Problem 285 285
Failure to Charge 284 284
No Display/Image 281 281
Partial Blockage 271 271
Failure to Power Up 266 266
Data Problem 262 262
Naturally Worn 253 253
Failure to Pump 242 242

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22191 22191
No Known Impact Or Consequence To Patient 16802 16803
No Consequences Or Impact To Patient 13431 13431
Blood Loss 9971 9972
Unspecified Infection 8884 8884
Death 8387 8387
Thrombus 6591 6591
Hemolysis 6162 6163
Insufficient Information 5170 5170
Bacterial Infection 4496 4496
Stroke/CVA 3917 3917
Hemorrhage/Bleeding 3872 3872
Heart Failure/Congestive Heart Failure 3751 3751
Thrombosis/Thrombus 3367 3367
Arrhythmia 2900 2900
Sepsis 2592 2592
Renal Failure 2488 2488
Skin Infection 2333 2333
Gastrointestinal Hemorrhage 2320 2320
Respiratory Failure 2118 2118
Neurological Deficit/Dysfunction 1925 1925
Hemorrhage, Cerebral 1872 1872
Dyspnea 1600 1600
Anemia 1501 1501
Multiple Organ Failure 1390 1390
Heart Failure 1353 1353
High Blood Pressure/ Hypertension 1307 1307
Dizziness 1283 1283
Hematuria 1197 1198
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1158 1158
Infarction, Cerebral 1154 1154
Intracranial Hemorrhage 1124 1125
Post Operative Wound Infection 1089 1089
Tachycardia 1076 1076
Cardiac Arrest 962 962
Hypervolemia 914 914
Fever 878 878
Thrombosis 877 877
Fatigue 841 841
Hemorrhagic Stroke 821 821
No Code Available 811 811
Unspecified Nervous System Problem 796 796
Right Ventricular Failure 789 789
Low Blood Pressure/ Hypotension 781 781
Lactate Dehydrogenase Increased 752 752
Thromboembolism 747 747
Hematoma 691 691
Syncope/Fainting 645 645
Ischemia Stroke 642 642
Pain 623 623

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 Abiomed, Inc. I Mar-04-2010
3 Abiomed, Inc. II Sep-16-2009
4 Abiomed, Inc. II Sep-01-2009
5 BERLIN HEART GMBH I May-25-2023
6 Datascope Corporation II Oct-24-2022
7 HeartWare Inc II Jun-26-2015
8 HeartWare Inc I Jun-13-2015
9 HeartWare Inc I Jun-11-2015
10 HeartWare Inc II Jun-10-2015
11 HeartWare Inc I Jun-08-2015
12 HeartWare Inc I May-14-2015
13 HeartWare Inc I Feb-25-2015
14 HeartWare Inc II May-14-2014
15 HeartWare Inc I Apr-23-2014
16 HeartWare Inc II Jul-29-2013
17 HeartWare, Inc I Oct-13-2016
18 Heartware I May-21-2018
19 Heartware I Apr-27-2017
20 Heartware I Apr-25-2017
21 Heartware Inc II May-14-2013
22 Heartware, Inc. II Dec-02-2023
23 Heartware, Inc. II Jun-22-2023
24 Heartware, Inc. II Dec-21-2022
25 Heartware, Inc. I Aug-18-2022
26 Heartware, Inc. II May-17-2022
27 Heartware, Inc. II Mar-04-2022
28 Heartware, Inc. II Sep-16-2021
29 Heartware, Inc. I Aug-06-2021
30 Heartware, Inc. II Jul-13-2021
31 Heartware, Inc. II Apr-21-2021
32 Heartware, Inc. II Apr-20-2021
33 Heartware, Inc. I Apr-16-2021
34 Heartware, Inc. I Apr-06-2021
35 Heartware, Inc. I May-22-2020
36 Heartware, Inc. I Mar-09-2020
37 Heartware, Inc. II Dec-07-2018
38 Heartware, Inc. II Oct-03-2018
39 Heartware, Inc. I Oct-17-2016
40 Heartware, Inc. I Jul-08-2016
41 Jarvik Heart Inc II Dec-18-2018
42 Medtronic Inc I Jun-21-2022
43 Medtronic Inc I Jun-03-2022
44 Medtronic Inc II May-17-2022
45 Medtronic Inc I Feb-04-2021
46 Thoratec Corp II Nov-24-2009
47 Thoratec Corp II Oct-13-2010
48 Thoratec Corp. I Jun-07-2024
49 Thoratec Corp. I May-01-2024
50 Thoratec Corp. I Mar-22-2024
51 Thoratec Corp. I Feb-02-2024
52 Thoratec Corp. II Sep-29-2023
53 Thoratec Corp. II Nov-26-2021
54 Thoratec Corp. II Dec-27-2019
55 Thoratec Corp. II Aug-22-2019
56 Thoratec Corp. II Apr-19-2019
57 Thoratec Corporation I May-24-2017
58 Thoratec Corporation I Mar-21-2014
59 Thoratec Corporation I Mar-23-2012
60 Thoratec LLC II Aug-13-2024
61 Thoratec Switzerland GMBH II Jun-27-2024
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