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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 27

MDR Year MDR Reports MDR Events
2018 12660 12660
2019 20216 20216
2020 14238 14238
2021 15765 15765
2022 15994 15994
2023 9366 9366

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 49012 49012
Battery Problem 5912 5912
Pumping Problem 5747 5747
Mechanical Problem 5111 5111
Power Problem 4611 4611
Infusion or Flow Problem 3473 3473
Pumping Stopped 3162 3162
Break 2666 2666
Connection Problem 1788 1788
Material Integrity Problem 1668 1668
Electrical Power Problem 1503 1503
Complete Loss of Power 1486 1486
Disconnection 1436 1436
Electrical /Electronic Property Problem 1400 1400
Obstruction of Flow 1293 1293
Material Twisted/Bent 1244 1244
Insufficient Information 1053 1053
Material Split, Cut or Torn 992 992
Decreased Pump Speed 976 976
Material Deformation 686 686
No Apparent Adverse Event 545 545
Communication or Transmission Problem 524 524
Use of Device Problem 494 494
Display or Visual Feedback Problem 452 452
Device Difficult to Setup or Prepare 424 424
Noise, Audible 370 370
High Readings 355 355
Device Stops Intermittently 345 345
Improper or Incorrect Procedure or Method 318 318
Increase in Suction 289 289
Malposition of Device 280 280
Appropriate Term/Code Not Available 277 277
Device Displays Incorrect Message 257 257
Loss of Power 256 256
Naturally Worn 223 223
Device Alarm System 221 221
Overheating of Device 210 210
Output Problem 200 200
No Audible Alarm 192 192
Data Problem 170 170
Failure to Charge 153 153
Failure to Power Up 151 151
Failure to Pump 133 133
Fluid/Blood Leak 125 125
Loose or Intermittent Connection 116 116
No Display/Image 113 113
Failure to Align 110 110
Leak/Splash 97 97
Partial Blockage 97 97
Detachment of Device or Device Component 87 87
Device Inoperable 86 86
Insufficient Flow or Under Infusion 84 84
Contamination /Decontamination Problem 81 81
Deformation Due to Compressive Stress 81 81
Electro-Static Discharge 80 80
Contamination 75 75
Crack 72 72
Restricted Flow rate 70 70
Date/Time-Related Software Problem 68 68
Incomplete or Inadequate Connection 68 68
Electromagnetic Interference 66 66
Low Audible Alarm 62 62
Device Fell 62 62
Display Difficult to Read 61 61
Material Discolored 59 59
Alarm Not Visible 59 59
Corroded 57 57
Vibration 55 55
Low Readings 55 55
Difficult to Remove 53 53
Electrical Shorting 53 53
Unintended Electrical Shock 51 51
Unexpected Shutdown 50 50
Fracture 50 50
Failure to Interrogate 50 50
Device Contamination with Chemical or Other Material 40 40
Premature Discharge of Battery 37 37
Kinked 35 35
Material Separation 34 34
Increased Pump Speed 34 34
Failure of Device to Self-Test 30 30
Protective Measures Problem 30 30
Device Operates Differently Than Expected 29 29
Therapeutic or Diagnostic Output Failure 28 28
Misconnection 27 27
Bent 27 27
Moisture Damage 26 26
Charging Problem 26 26
Premature Separation 24 24
Nonstandard Device 24 24
Device Damaged Prior to Use 24 24
Component Missing 24 24
Fitting Problem 24 24
Defective Device 22 22
Device Misassembled During Manufacturing /Shipping 21 21
Manufacturing, Packaging or Shipping Problem 21 21
Improper Flow or Infusion 21 21
Torn Material 21 21
Microbial Contamination of Device 21 21
Tear, Rip or Hole in Device Packaging 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16249 16249
No Known Impact Or Consequence To Patient 11826 11827
Blood Loss 8054 8055
Unspecified Infection 6893 6893
Death 5095 5095
No Consequences Or Impact To Patient 5057 5057
Insufficient Information 4031 4031
Bacterial Infection 3601 3601
Hemolysis 3418 3418
Thrombus 3223 3223
Stroke/CVA 3106 3106
Hemorrhage/Bleeding 3105 3105
Heart Failure/Congestive Heart Failure 2881 2881
Thrombosis/Thrombus 2720 2720
Arrhythmia 2097 2097
Renal Failure 1960 1960
Sepsis 1935 1935
Gastrointestinal Hemorrhage 1921 1921
Skin Infection 1842 1842
Respiratory Failure 1698 1698
Neurological Deficit/Dysfunction 1072 1072
Dyspnea 1054 1054
Anemia 1049 1049
Hemorrhage, Cerebral 996 996
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 902 902
Heart Failure 871 871
Intracranial Hemorrhage 832 833
Tachycardia 826 826
Thrombosis 760 760
Dizziness 754 754
Multiple Organ Failure 743 743
Hematuria 688 688
Hypervolemia 681 681
Hemorrhagic Stroke 677 677
Unspecified Nervous System Problem 664 664
Fever 663 663
Cardiac Arrest 652 652
High Blood Pressure/ Hypertension 644 644
Thromboembolism 627 627
Infarction, Cerebral 596 596
Lactate Dehydrogenase Increased 586 586
Right Ventricular Failure 584 584
Fatigue 559 559
Low Blood Pressure/ Hypotension 543 543
Hematoma 538 538
Syncope/Fainting 513 513
Atrial Fibrillation 505 505
Ischemia Stroke 491 491
Muscle Weakness 427 427
Cardiogenic Shock 427 427
Weakness 425 425
Pain 424 424
No Code Available 402 402
Pneumonia 389 389
Ventricular Tachycardia 365 365
Post Operative Wound Infection 359 359
Fall 352 352
Wound Dehiscence 351 351
Loss of consciousness 350 350
Ventricular Fibrillation 348 348
Obstruction/Occlusion 346 346
Transient Ischemic Attack 338 338
Aortic Valve Insufficiency/ Regurgitation 328 328
Confusion/ Disorientation 327 327
Pleural Effusion 325 325
Chest Pain 323 323
Headache 305 305
Nausea 293 293
Renal Impairment 283 283
Septic Shock 280 280
Syncope 273 273
Melena 272 272
Ischemia 270 270
Epistaxis 254 254
Purulent Discharge 253 253
Vomiting 248 248
No Patient Involvement 247 247
Cardiac Tamponade 236 236
Liver Damage/Dysfunction 234 234
Encephalopathy 229 229
Hypovolemia 229 229
Abdominal Pain 226 226
Pericardial Effusion 201 201
Swelling/ Edema 197 197
Hypoxia 196 196
Aortic Insufficiency 176 176
Dehydration 175 175
Convulsion/Seizure 171 171
Fungal Infection 164 164
Hemorrhage, Subarachnoid 162 162
Fluid Discharge 156 156
Right Ventricular Dysfunction 148 148
Drug Resistant Bacterial Infection 147 147
Liver Failure 144 144
Seizures 143 143
Dysphasia 142 142
Pulmonary Edema 136 136
Paralysis 135 135
No Information 134 134
Urinary Tract Infection 132 132

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 BERLIN HEART GMBH I May-25-2023
3 Datascope Corporation II Oct-24-2022
4 Heartware I May-21-2018
5 Heartware, Inc. II Jun-22-2023
6 Heartware, Inc. II Dec-21-2022
7 Heartware, Inc. I Aug-18-2022
8 Heartware, Inc. II May-17-2022
9 Heartware, Inc. II Mar-04-2022
10 Heartware, Inc. II Sep-16-2021
11 Heartware, Inc. I Aug-06-2021
12 Heartware, Inc. II Jul-13-2021
13 Heartware, Inc. II Apr-21-2021
14 Heartware, Inc. II Apr-20-2021
15 Heartware, Inc. I Apr-16-2021
16 Heartware, Inc. I Apr-06-2021
17 Heartware, Inc. I May-22-2020
18 Heartware, Inc. I Mar-09-2020
19 Heartware, Inc. II Dec-07-2018
20 Heartware, Inc. II Oct-03-2018
21 Jarvik Heart Inc II Dec-18-2018
22 Medtronic Inc I Jun-21-2022
23 Medtronic Inc I Jun-03-2022
24 Medtronic Inc II May-17-2022
25 Medtronic Inc I Feb-04-2021
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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