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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)
2019 2020 2021 2022 2023 2024
34 48 38 33 48 23

MDR Year MDR Reports MDR Events
2019 20216 20216
2020 14238 14238
2021 15765 15765
2022 15994 15994
2023 13056 13056
2024 4311 4311

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 47786 47786
Pumping Problem 5900 5900
Mechanical Problem 5874 5874
Battery Problem 4957 4957
Power Problem 3546 3546
Infusion or Flow Problem 3506 3506
Pumping Stopped 2914 2914
Electrical Power Problem 1786 1786
Complete Loss of Power 1710 1710
Break 1677 1677
Disconnection 1547 1547
Electrical /Electronic Property Problem 1538 1538
Material Integrity Problem 1447 1447
Insufficient Information 1263 1263
Material Twisted/Bent 1205 1205
Connection Problem 1044 1044
Decreased Pump Speed 968 968
Obstruction of Flow 911 911
Material Split, Cut or Torn 899 899
No Apparent Adverse Event 755 755
Communication or Transmission Problem 602 602
Device Difficult to Setup or Prepare 523 523
Material Deformation 510 510
Use of Device Problem 493 493
Display or Visual Feedback Problem 477 477
Improper or Incorrect Procedure or Method 407 407
Noise, Audible 379 379
Increase in Suction 262 262
Malposition of Device 244 244
Overheating of Device 242 242
Appropriate Term/Code Not Available 210 210
Loss of Power 197 197
Failure to Charge 192 192
Failure to Pump 188 188
No Audible Alarm 186 186
Data Problem 172 172
Naturally Worn 171 171
Device Alarm System 164 164
Failure to Power Up 158 158
Fluid/Blood Leak 156 156
Failure to Align 144 144
Output Problem 144 144
Contamination /Decontamination Problem 107 107
High Readings 106 106
No Display/Image 104 104
Electro-Static Discharge 95 95
Deformation Due to Compressive Stress 92 92
Display Difficult to Read 90 90
Corroded 86 86
Electromagnetic Interference 83 83
Detachment of Device or Device Component 82 82
Loose or Intermittent Connection 75 75
Dull, Blunt 72 72
Leak/Splash 70 70
Alarm Not Visible 69 69
Low Audible Alarm 68 68
Material Discolored 66 66
Failure to Interrogate 65 65
Insufficient Flow or Under Infusion 65 65
Incomplete or Inadequate Connection 63 63
Device Fell 61 61
Contamination 60 60
Date/Time-Related Software Problem 58 58
Unintended Electrical Shock 56 56
Unexpected Shutdown 56 56
Difficult to Remove 54 54
Fracture 50 50
Crack 45 45
Premature Discharge of Battery 43 43
Vibration 43 43
Device Displays Incorrect Message 38 38
Low Readings 38 38
Increased Pump Speed 35 35
Failure of Device to Self-Test 34 34
Therapeutic or Diagnostic Output Failure 28 28
Moisture Damage 28 28
Material Separation 27 27
Premature Separation 27 27
Off-Label Use 26 26
Misconnection 26 26
Device Contamination with Chemical or Other Material 25 25
Protective Measures Problem 24 24
Gas/Air Leak 21 21
Manufacturing, Packaging or Shipping Problem 21 21
Electrical Shorting 20 20
Material Too Rigid or Stiff 20 20
Component Missing 19 19
Fitting Problem 18 18
Microbial Contamination of Device 18 18
Tear, Rip or Hole in Device Packaging 18 18
Nonstandard Device 18 18
Environmental Compatibility Problem 17 17
Material Protrusion/Extrusion 17 17
Improper Flow or Infusion 17 17
Patient Device Interaction Problem 15 15
Sparking 15 15
Separation Failure 15 15
Defective Device 13 13
Product Quality Problem 13 13
Material Puncture/Hole 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19938 19938
No Known Impact Or Consequence To Patient 6708 6708
Blood Loss 6483 6483
Unspecified Infection 5750 5750
Insufficient Information 4827 4827
No Consequences Or Impact To Patient 4558 4558
Bacterial Infection 4000 4000
Death 3783 3783
Hemorrhage/Bleeding 3432 3432
Heart Failure/Congestive Heart Failure 3421 3421
Thrombosis/Thrombus 3113 3113
Stroke/CVA 2773 2773
Hemolysis 2759 2759
Arrhythmia 2203 2203
Skin Infection 2169 2169
Gastrointestinal Hemorrhage 2166 2166
Thrombus 2045 2045
Renal Failure 1999 1999
Sepsis 1855 1855
Respiratory Failure 1721 1721
Dyspnea 1079 1079
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1078 1078
Anemia 1019 1019
Tachycardia 948 948
Intracranial Hemorrhage 907 907
Hypervolemia 800 800
Multiple Organ Failure 800 800
Hemorrhagic Stroke 781 781
Unspecified Nervous System Problem 729 729
Dizziness 719 719
Cardiac Arrest 695 695
Neurological Deficit/Dysfunction 691 691
Lactate Dehydrogenase Increased 691 691
Hemorrhage, Cerebral 687 687
High Blood Pressure/ Hypertension 682 682
Fever 661 661
Heart Failure 653 653
Ischemia Stroke 602 602
Syncope/Fainting 597 597
Hematuria 589 589
Low Blood Pressure/ Hypotension 586 586
Thromboembolism 582 582
Hematoma 572 572
Thrombosis 553 553
Fatigue 529 529
Atrial Fibrillation 517 517
Muscle Weakness 475 475
Infarction, Cerebral 457 457
Cardiogenic Shock 455 455
Right Ventricular Failure 448 448
Pneumonia 448 448
Pain 400 400
Aortic Valve Insufficiency/ Regurgitation 394 394
Loss of consciousness 382 382
Ventricular Fibrillation 374 374
Obstruction/Occlusion 370 370
Fall 362 362
Renal Impairment 342 342
No Code Available 338 338
Chest Pain 335 335
Transient Ischemic Attack 334 334
Weakness 325 325
Confusion/ Disorientation 324 324
Melena 323 323
Pleural Effusion 313 313
Headache 311 311
Septic Shock 301 301
Nausea 300 300
Wound Dehiscence 296 296
Ventricular Tachycardia 293 293
Purulent Discharge 290 290
Epistaxis 281 281
Ischemia 269 269
Vomiting 259 259
Hypovolemia 256 256
Swelling/ Edema 244 244
Encephalopathy 239 239
Abdominal Pain 237 237
Post Operative Wound Infection 229 229
Liver Damage/Dysfunction 223 223
Cardiac Tamponade 216 216
Hypoxia 211 211
Fluid Discharge 206 206
Drug Resistant Bacterial Infection 201 201
Convulsion/Seizure 195 195
Fungal Infection 195 195
Pericardial Effusion 193 193
No Patient Involvement 191 191
Syncope 190 190
Dehydration 184 184
Liver Failure 167 167
Urinary Tract Infection 149 149
Paralysis 149 149
Dysphasia 148 148
Viral Infection 141 141
Pulmonary Edema 137 137
Abscess 130 130
Presyncope 129 129
Seizures 124 124
No Information 123 123

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 May-01-2024
23 Thoratec Corp. I Mar-22-2024
24 Thoratec Corp. I Feb-02-2024
25 Thoratec Corp. II Sep-29-2023
26 Thoratec Corp. II Nov-26-2021
27 Thoratec Corp. II Dec-27-2019
28 Thoratec Corp. II Aug-22-2019
29 Thoratec Corp. II Apr-19-2019
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