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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 18

MDR Year MDR Reports MDR Events
2019 20216 20216
2020 14238 14238
2021 15765 15765
2022 15994 15994
2023 13056 13056
2024 3085 3085

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 47303 47303
Mechanical Problem 5761 5761
Pumping Problem 5620 5620
Battery Problem 4909 4909
Power Problem 3505 3505
Infusion or Flow Problem 3390 3390
Pumping Stopped 2881 2881
Electrical Power Problem 1731 1731
Complete Loss of Power 1675 1675
Break 1671 1671
Disconnection 1520 1520
Electrical /Electronic Property Problem 1511 1511
Material Integrity Problem 1425 1425
Insufficient Information 1218 1218
Material Twisted/Bent 1199 1199
Connection Problem 1044 1044
Decreased Pump Speed 951 951
Obstruction of Flow 908 908
Material Split, Cut or Torn 899 899
No Apparent Adverse Event 727 727
Communication or Transmission Problem 587 587
Device Difficult to Setup or Prepare 506 506
Material Deformation 501 501
Use of Device Problem 467 467
Display or Visual Feedback Problem 461 461
Improper or Incorrect Procedure or Method 391 391
Noise, Audible 365 365
Increase in Suction 260 260
Malposition of Device 242 242
Overheating of Device 232 232
Appropriate Term/Code Not Available 209 209
Loss of Power 197 197
Failure to Charge 183 183
Failure to Pump 182 182
No Audible Alarm 178 178
Naturally Worn 171 171
Data Problem 166 166
Device Alarm System 163 163
Failure to Power Up 158 158
Output Problem 143 143
Fluid/Blood Leak 138 138
Failure to Align 137 137
High Readings 106 106
No Display/Image 103 103
Contamination /Decontamination Problem 102 102
Deformation Due to Compressive Stress 91 91
Electro-Static Discharge 89 89
Display Difficult to Read 86 86
Corroded 85 85
Detachment of Device or Device Component 82 82
Electromagnetic Interference 80 80
Loose or Intermittent Connection 75 75
Leak/Splash 69 69
Alarm Not Visible 69 69
Low Audible Alarm 67 67
Insufficient Flow or Under Infusion 65 65
Dull, Blunt 65 65
Material Discolored 64 64
Failure to Interrogate 63 63
Incomplete or Inadequate Connection 63 63
Device Fell 61 61
Contamination 58 58
Date/Time-Related Software Problem 57 57
Unexpected Shutdown 55 55
Difficult to Remove 54 54
Unintended Electrical Shock 53 53
Fracture 50 50
Crack 45 45
Premature Discharge of Battery 43 43
Vibration 42 42
Device Displays Incorrect Message 38 38
Low Readings 38 38
Increased Pump Speed 35 35
Failure of Device to Self-Test 33 33
Therapeutic or Diagnostic Output Failure 28 28
Premature Separation 27 27
Material Separation 27 27
Moisture Damage 27 27
Misconnection 26 26
Off-Label Use 25 25
Device Contamination with Chemical or Other Material 25 25
Protective Measures Problem 24 24
Manufacturing, Packaging or Shipping Problem 21 21
Gas/Air Leak 20 20
Electrical Shorting 20 20
Material Too Rigid or Stiff 19 19
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
Improper Flow or Infusion 17 17
Material Protrusion/Extrusion 17 17
Patient Device Interaction Problem 15 15
Sparking 15 15
Defective Device 13 13
Separation Failure 12 12
Material Puncture/Hole 12 12
Product Quality Problem 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19272 19272
No Known Impact Or Consequence To Patient 6708 6708
Blood Loss 6483 6483
Unspecified Infection 5726 5726
Insufficient Information 4733 4733
No Consequences Or Impact To Patient 4558 4558
Bacterial Infection 3936 3936
Death 3783 3783
Hemorrhage/Bleeding 3377 3377
Heart Failure/Congestive Heart Failure 3342 3342
Thrombosis/Thrombus 3054 3054
Stroke/CVA 2760 2760
Hemolysis 2751 2751
Arrhythmia 2192 2192
Gastrointestinal Hemorrhage 2143 2143
Skin Infection 2113 2113
Thrombus 2045 2045
Renal Failure 1982 1982
Sepsis 1841 1841
Respiratory Failure 1708 1708
Dyspnea 1058 1058
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1031 1031
Anemia 1013 1013
Tachycardia 930 930
Intracranial Hemorrhage 888 888
Hypervolemia 792 792
Hemorrhagic Stroke 771 771
Multiple Organ Failure 761 761
Unspecified Nervous System Problem 724 724
Dizziness 701 701
Neurological Deficit/Dysfunction 691 691
Hemorrhage, Cerebral 687 687
Lactate Dehydrogenase Increased 676 676
High Blood Pressure/ Hypertension 673 673
Cardiac Arrest 673 673
Heart Failure 653 653
Fever 651 651
Syncope/Fainting 586 586
Ischemia Stroke 583 583
Thromboembolism 582 582
Hematuria 582 582
Low Blood Pressure/ Hypotension 576 576
Hematoma 563 563
Thrombosis 553 553
Fatigue 518 518
Atrial Fibrillation 513 513
Muscle Weakness 471 471
Infarction, Cerebral 457 457
Right Ventricular Failure 448 448
Cardiogenic Shock 443 443
Pneumonia 441 441
Pain 397 397
Aortic Valve Insufficiency/ Regurgitation 384 384
Loss of consciousness 368 368
Ventricular Fibrillation 368 368
Obstruction/Occlusion 365 365
Fall 360 360
No Code Available 338 338
Renal Impairment 332 332
Transient Ischemic Attack 331 331
Weakness 325 325
Chest Pain 321 321
Confusion/ Disorientation 320 320
Melena 313 313
Pleural Effusion 311 311
Headache 307 307
Wound Dehiscence 296 296
Nausea 294 294
Ventricular Tachycardia 293 293
Septic Shock 289 289
Epistaxis 277 277
Purulent Discharge 275 275
Ischemia 268 268
Vomiting 254 254
Hypovolemia 252 252
Swelling/ Edema 241 241
Encephalopathy 235 235
Abdominal Pain 232 232
Post Operative Wound Infection 225 225
Liver Damage/Dysfunction 216 216
Cardiac Tamponade 215 215
Hypoxia 206 206
Fluid Discharge 197 197
Convulsion/Seizure 192 192
Pericardial Effusion 191 191
Fungal Infection 191 191
No Patient Involvement 191 191
Drug Resistant Bacterial Infection 190 190
Syncope 190 190
Dehydration 182 182
Liver Failure 167 167
Urinary Tract Infection 149 149
Paralysis 149 149
Dysphasia 148 148
Viral Infection 141 141
Pulmonary Edema 134 134
Abscess 126 126
Seizures 124 124
No Information 123 123
Right Ventricular Dysfunction 122 122

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