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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)
2020 2021 2022 2023 2024 2025
48 38 33 48 61 32

MDR Year MDR Reports MDR Events
2020 14238 14238
2021 15765 15765
2022 15994 15994
2023 13056 13056
2024 13047 13047
2025 5497 5497

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 42922 42922
Mechanical Problem 7112 7112
Pumping Problem 5298 5298
Infusion or Flow Problem 4501 4501
Battery Problem 4491 4491
Pumping Stopped 2660 2660
Electrical Power Problem 2452 2452
Complete Loss of Power 2061 2061
Disconnection 1959 1959
Electrical /Electronic Property Problem 1848 1848
Power Problem 1843 1843
Insufficient Information 1659 1659
Material Integrity Problem 1475 1475
No Apparent Adverse Event 1277 1277
Break 961 961
Material Twisted/Bent 956 956
Decreased Pump Speed 894 894
Display or Visual Feedback Problem 873 873
Communication or Transmission Problem 780 780
Use of Device Problem 740 740
Material Split, Cut or Torn 709 709
Device Difficult to Setup or Prepare 675 675
Material Deformation 647 647
Connection Problem 637 637
Obstruction of Flow 633 633
Improper or Incorrect Procedure or Method 566 566
Noise, Audible 417 417
Failure to Charge 415 415
Overheating of Device 289 289
Increase in Suction 258 258
Failure to Pump 226 226
Malposition of Device 215 215
No Audible Alarm 213 213
Fluid/Blood Leak 208 208
Failure to Power Up 195 195
Failure to Align 187 187
Display Difficult to Read 183 183
Corroded 166 166
Data Problem 164 164
Contamination /Decontamination Problem 150 150
Electromagnetic Interference 132 132
Device Alarm System 132 132
No Display/Image 129 129
Electro-Static Discharge 119 119
Alarm Not Visible 101 101
Deformation Due to Compressive Stress 100 100
Failure to Interrogate 98 98
Appropriate Term/Code Not Available 96 96
Low Audible Alarm 96 96
Loss of Power 96 96

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26341 26341
Insufficient Information 6124 6124
Heart Failure/Congestive Heart Failure 4423 4423
Unspecified Infection 4285 4285
Bacterial Infection 4045 4045
Hemorrhage/Bleeding 3929 3929
Thrombosis/Thrombus 3778 3778
No Consequences Or Impact To Patient 3649 3649
Skin Infection 2612 2612
Gastrointestinal Hemorrhage 2584 2584
Arrhythmia 2526 2526
Blood Loss 2363 2363
Hemolysis 2150 2150
Stroke/CVA 2142 2142
Renal Failure 1972 1972
Death 1706 1706
Respiratory Failure 1607 1607
Sepsis 1499 1499
High Blood Pressure/ Hypertension 1279 1279
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1251 1251
Tachycardia 1232 1232
Dyspnea 1203 1203
Intracranial Hemorrhage 1062 1062
No Known Impact Or Consequence To Patient 999 999
Hypervolemia 975 975
Hemorrhagic Stroke 918 918
Multiple Organ Failure 918 918
Unspecified Nervous System Problem 849 849
Lactate Dehydrogenase Increased 837 837
Cardiac Arrest 831 831
Anemia 831 831
Dizziness 808 808
Thrombus 796 796
Ischemia Stroke 785 785
Syncope/Fainting 771 771
Fever 699 699
Low Blood Pressure/ Hypotension 680 680
Muscle Weakness 571 571
Hematoma 568 568
Aortic Valve Insufficiency/ Regurgitation 567 567
Fatigue 562 562
Pneumonia 546 546
Atrial Fibrillation 543 543
Ventricular Fibrillation 521 521
Cardiogenic Shock 518 518
Thromboembolism 485 485
Hematuria 479 479
Renal Impairment 462 462
Loss of consciousness 429 429
Pain 421 421

Recalls
Manufacturer Recall Class Date Posted
1 BERLIN HEART GMBH I May-25-2023
2 Datascope Corporation II Oct-24-2022
3 Heartware, Inc. II Dec-02-2023
4 Heartware, Inc. II Jun-22-2023
5 Heartware, Inc. II Dec-21-2022
6 Heartware, Inc. I Aug-18-2022
7 Heartware, Inc. II May-17-2022
8 Heartware, Inc. II Mar-04-2022
9 Heartware, Inc. II Sep-16-2021
10 Heartware, Inc. I Aug-06-2021
11 Heartware, Inc. II Jul-13-2021
12 Heartware, Inc. II Apr-21-2021
13 Heartware, Inc. II Apr-20-2021
14 Heartware, Inc. I Apr-16-2021
15 Heartware, Inc. I Apr-06-2021
16 Heartware, Inc. I May-22-2020
17 Heartware, Inc. I Mar-09-2020
18 Medtronic Inc I Jun-21-2022
19 Medtronic Inc I Jun-03-2022
20 Medtronic Inc II May-17-2022
21 Medtronic Inc I Feb-04-2021
22 Thoratec Corp. I Jun-07-2024
23 Thoratec Corp. I May-01-2024
24 Thoratec Corp. I Mar-22-2024
25 Thoratec Corp. I Feb-02-2024
26 Thoratec Corp. II Sep-29-2023
27 Thoratec Corp. II Nov-26-2021
28 Thoratec LLC I Apr-17-2025
29 Thoratec LLC II Aug-13-2024
30 Thoratec Switzerland GMBH II Jun-27-2024
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