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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)
2018 2019 2020 2021 2022 2023
35 34 48 38 33 3

MDR Year MDR Reports MDR Events
2018 12660 12660
2019 20216 20216
2020 14238 14238
2021 15766 15766
2022 16000 16000

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 43145 43145
Battery Problem 5363 5363
Pumping Problem 5358 5358
Power Problem 4457 4457
Mechanical Problem 4365 4365
Infusion or Flow Problem 2985 2985
Pumping Stopped 2884 2884
Break 2582 2582
Connection Problem 1739 1739
Material Integrity Problem 1464 1464
Electrical Power Problem 1260 1260
Obstruction of Flow 1243 1243
Complete Loss of Power 1242 1242
Electrical /Electronic Property Problem 1213 1213
Disconnection 1202 1202
Material Twisted/Bent 1160 1160
Material Split, Cut or Torn 949 949
Decreased Pump Speed 921 921
Insufficient Information 830 830
Material Deformation 608 608
Use of Device Problem 431 431
Communication or Transmission Problem 425 425
No Apparent Adverse Event 403 403
Display or Visual Feedback Problem 360 360
High Readings 355 355
Device Stops Intermittently 345 345
Noise, Audible 329 329
Device Difficult to Setup or Prepare 323 323
Appropriate Term/Code Not Available 270 270
Malposition of Device 266 266
Increase in Suction 262 262
Device Displays Incorrect Message 256 256
Loss of Power 255 255
Naturally Worn 222 222
Improper or Incorrect Procedure or Method 208 208
Device Alarm System 204 204
Output Problem 196 196
Overheating of Device 179 179
No Audible Alarm 174 174
Data Problem 146 146
Failure to Charge 134 134
Failure to Power Up 118 118
Loose or Intermittent Connection 112 112
Failure to Pump 107 107
Fluid/Blood Leak 104 104
No Display/Image 98 98
Partial Blockage 96 96
Failure to Align 95 95
Leak/Splash 86 86
Device Inoperable 86 86
Insufficient Flow or Under Infusion 83 83
Detachment of Device or Device Component 77 77
Deformation Due to Compressive Stress 72 72
Contamination 71 71
Restricted Flow rate 70 70
Crack 69 69
Incomplete or Inadequate Connection 65 65
Contamination /Decontamination Problem 64 64
Device Fell 62 62
Electro-Static Discharge 62 62
Date/Time-Related Software Problem 59 59
Electromagnetic Interference 56 56
Low Readings 55 55
Low Audible Alarm 53 53
Electrical Shorting 53 53
Vibration 51 51
Alarm Not Visible 48 48
Material Discolored 48 48
Fracture 46 46
Difficult to Remove 43 43
Unintended Electrical Shock 42 42
Display Difficult to Read 40 40
Unexpected Shutdown 39 39
Corroded 37 37
Kinked 35 35
Device Contamination with Chemical or Other Material 35 35
Premature Discharge of Battery 33 33
Material Separation 33 33
Device Operates Differently Than Expected 29 29
Protective Measures Problem 28 28
Therapeutic or Diagnostic Output Failure 28 28
Failure to Interrogate 28 28
Bent 27 27
Misconnection 26 26
Moisture Damage 24 24
Increased Pump Speed 24 24
Fitting Problem 24 24
Device Damaged Prior to Use 24 24
Charging Problem 24 24
Failure of Device to Self-Test 23 23
Component Missing 23 23
Microbial Contamination of Device 21 21
Device Misassembled During Manufacturing /Shipping 21 21
Torn Material 21 21
Defective Device 20 20
Improper Flow or Infusion 20 20
Manufacturing, Packaging or Shipping Problem 20 20
Material Protrusion/Extrusion 20 20
Tear, Rip or Hole in Device Packaging 20 20
Misassembled 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13156 13156
No Known Impact Or Consequence To Patient 11826 11827
Blood Loss 8054 8055
Unspecified Infection 6491 6491
Death 5095 5095
No Consequences Or Impact To Patient 5057 5057
Hemolysis 3239 3239
Thrombus 3223 3223
Bacterial Infection 3078 3078
Stroke/CVA 2853 2853
Hemorrhage/Bleeding 2670 2670
Heart Failure/Congestive Heart Failure 2338 2338
Thrombosis/Thrombus 2253 2253
Insufficient Information 2108 2108
Arrhythmia 1922 1922
Sepsis 1747 1747
Renal Failure 1738 1738
Gastrointestinal Hemorrhage 1584 1584
Respiratory Failure 1554 1554
Skin Infection 1397 1397
Neurological Deficit/Dysfunction 1072 1072
Hemorrhage, Cerebral 996 996
Anemia 972 972
Dyspnea 876 876
Heart Failure 871 871
Thrombosis 760 760
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 705 705
Intracranial Hemorrhage 704 705
Tachycardia 676 676
Dizziness 652 652
Hematuria 642 642
Multiple Organ Failure 629 629
Infarction, Cerebral 596 596
Fever 585 585
Right Ventricular Failure 584 584
High Blood Pressure/ Hypertension 580 580
Thromboembolism 576 576
Unspecified Nervous System Problem 569 569
Hemorrhagic Stroke 544 544
Cardiac Arrest 519 519
Hypervolemia 490 490
Fatigue 487 487
Low Blood Pressure/ Hypotension 473 473
Lactate Dehydrogenase Increased 472 472
Atrial Fibrillation 471 471
Hematoma 466 466
Syncope/Fainting 432 432
Weakness 425 425
No Code Available 402 402
Ischemia Stroke 381 381
Pain 377 377
Cardiogenic Shock 375 375
Ventricular Tachycardia 365 365
Muscle Weakness 360 360
Wound Dehiscence 338 338
Obstruction/Occlusion 315 315
Post Operative Wound Infection 313 313
Transient Ischemic Attack 310 310
Pneumonia 307 307
Pleural Effusion 302 302
Fall 297 297
Ventricular Fibrillation 291 291
Loss of consciousness 290 290
Confusion/ Disorientation 285 285
Headache 279 279
Syncope 273 273
Chest Pain 266 266
Nausea 255 255
Aortic Valve Insufficiency/ Regurgitation 251 251
No Patient Involvement 247 247
Ischemia 236 236
Septic Shock 234 234
Melena 222 222
Renal Impairment 220 220
Cardiac Tamponade 219 219
Vomiting 218 218
Encephalopathy 212 212
Liver Damage/Dysfunction 207 207
Epistaxis 202 202
Hypovolemia 200 200
Pericardial Effusion 195 195
Purulent Discharge 193 193
Abdominal Pain 193 193
Aortic Insufficiency 176 176
Hypoxia 166 166
Hemorrhage, Subarachnoid 162 162
Swelling/ Edema 152 152
Dehydration 148 148
Right Ventricular Dysfunction 148 148
Seizures 143 143
Convulsion/Seizure 139 139
No Information 134 134
Fungal Infection 133 133
Dysphasia 129 129
Liver Failure 122 122
Coma 121 121
Paralysis 117 117
Pulmonary Edema 113 113
Urinary Tract Infection 113 113
Abscess 112 112

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 Datascope Corporation II Oct-24-2022
3 Heartware I May-21-2018
4 Heartware, Inc. II Dec-21-2022
5 Heartware, Inc. I Aug-18-2022
6 Heartware, Inc. II May-17-2022
7 Heartware, Inc. II Mar-04-2022
8 Heartware, Inc. II Sep-16-2021
9 Heartware, Inc. I Aug-06-2021
10 Heartware, Inc. II Jul-13-2021
11 Heartware, Inc. II Apr-21-2021
12 Heartware, Inc. II Apr-20-2021
13 Heartware, Inc. I Apr-16-2021
14 Heartware, Inc. I Apr-06-2021
15 Heartware, Inc. I May-22-2020
16 Heartware, Inc. I Mar-09-2020
17 Heartware, Inc. II Dec-07-2018
18 Heartware, Inc. II Oct-03-2018
19 Jarvik Heart Inc II Dec-18-2018
20 Medtronic Inc I Jun-21-2022
21 Medtronic Inc I Jun-03-2022
22 Medtronic Inc II May-17-2022
23 Medtronic Inc I Feb-04-2021
24 Thoratec Corp. II Nov-26-2021
25 Thoratec Corp. II Dec-27-2019
26 Thoratec Corp. II Aug-22-2019
27 Thoratec Corp. II Apr-19-2019
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