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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)
2017 2018 2019 2020 2021 2022
36 35 34 48 38 3

MDR Year MDR Reports MDR Events
2017 9055 9055
2018 12660 12660
2019 20216 20216
2020 14238 14238
2021 15764 15764

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36055 36055
Battery Problem 5294 5294
Power Problem 4863 4863
Pumping Problem 4805 4805
Break 3089 3089
Mechanical Problem 2913 2913
Infusion or Flow Problem 2700 2700
Pumping Stopped 2522 2522
Connection Problem 2081 2081
Material Integrity Problem 1732 1732
Obstruction of Flow 1374 1374
Material Twisted/Bent 990 990
Electrical /Electronic Property Problem 969 969
Device Stops Intermittently 942 942
Disconnection 935 935
Electrical Power Problem 872 872
Complete Loss of Power 848 848
Decreased Pump Speed 843 843
Material Split, Cut or Torn 837 837
High Readings 745 745
Insufficient Information 692 692
Loose or Intermittent Connection 646 646
Material Deformation 631 631
Device Displays Incorrect Message 418 418
Use of Device Problem 404 404
Communication or Transmission Problem 315 315
Malposition of Device 276 276
Display or Visual Feedback Problem 267 267
Loss of Power 256 256
Appropriate Term/Code Not Available 250 250
Naturally Worn 229 229
No Apparent Adverse Event 219 219
Device Alarm System 213 213
Noise, Audible 212 212
Output Problem 200 200
Partial Blockage 200 200
Device Difficult to Setup or Prepare 194 194
Protective Measures Problem 181 181
Restricted Flow rate 179 179
No Audible Alarm 178 178
Increase in Suction 169 169
Overheating of Device 163 163
Data Problem 144 144
Electrical Shorting 131 131
Date/Time-Related Software Problem 125 125
Device Inoperable 116 116
No Display/Image 112 112
Crack 108 108
Leak/Splash 106 106
Improper or Incorrect Procedure or Method 104 104
Failure to Pump 92 92
Failure to Charge 92 92
Insufficient Flow or Under Infusion 87 87
Device Operates Differently Than Expected 70 70
Contamination 69 69
Failure to Power Up 68 68
Kinked 67 67
Low Readings 65 65
Fluid Leak 64 64
Detachment of Device or Device Component 62 62
Incomplete or Inadequate Connection 61 61
Deformation Due to Compressive Stress 57 57
Device Fell 54 54
Torn Material 53 53
Fracture 50 50
Low Audible Alarm 48 48
Failure to Align 46 46
Contamination /Decontamination Problem 44 44
Electro-Static Discharge 43 43
Vibration 43 43
Occlusion Within Device 42 42
Bent 41 41
Material Separation 40 40
Device Contamination with Chemical or Other Material 40 40
Alarm Not Visible 39 39
Material Discolored 37 37
Electromagnetic Interference 36 36
Difficult to Remove 34 34
Migration or Expulsion of Device 32 32
Cut In Material 30 30
Fitting Problem 28 28
Device Damaged Prior to Use 27 27
Moisture Damage 27 27
Unintended Electrical Shock 26 26
Component Missing 25 25
Microbial Contamination of Device 24 24
Premature Discharge of Battery 24 24
Corroded 24 24
Charging Problem 24 24
Improper Flow or Infusion 23 23
Maintenance Does Not Comply To Manufacturers Recommendations 23 23
Material Protrusion/Extrusion 23 23
Therapeutic or Diagnostic Output Failure 22 22
Device Misassembled During Manufacturing /Shipping 21 21
Misassembled 21 21
Misconnection 20 20
Display Difficult to Read 20 20
Tear, Rip or Hole in Device Packaging 19 19
Manufacturing, Packaging or Shipping Problem 19 19
Unexpected Shutdown 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13818 13819
Blood Loss 8872 8873
No Clinical Signs, Symptoms or Conditions 7735 7735
No Consequences Or Impact To Patient 7394 7394
Death 5966 5966
Unspecified Infection 5803 5803
Thrombus 4353 4353
Hemolysis 3379 3380
Stroke/CVA 2566 2566
Bacterial Infection 2211 2211
Hemorrhage/Bleeding 1654 1654
Sepsis 1580 1580
Neurological Deficit/Dysfunction 1436 1436
Renal Failure 1378 1378
Thrombosis/Thrombus 1357 1357
Arrhythmia 1343 1343
Hemorrhage, Cerebral 1310 1310
Respiratory Failure 1275 1275
Heart Failure/Congestive Heart Failure 1081 1081
Heart Failure 1025 1025
Insufficient Information 989 989
Anemia 918 918
Gastrointestinal Hemorrhage 877 877
Infarction, Cerebral 794 794
Thrombosis 788 788
Multiple Organ Failure 714 714
Dyspnea 672 672
Post Operative Wound Infection 669 669
Hematuria 657 658
Right Ventricular Failure 652 652
Skin Infection 613 613
Dizziness 583 583
Intracranial Hemorrhage 520 521
Thromboembolism 516 516
Weakness 480 480
Fever 454 454
Fatigue 446 446
No Code Available 437 437
Ventricular Tachycardia 409 409
Cardiac Arrest 404 404
Hematoma 386 386
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 370 370
Syncope 350 350
Hemorrhagic Stroke 338 338
Pain 334 334
Low Blood Pressure/ Hypotension 332 332
Tachycardia 320 320
Cardiogenic Shock 308 308
Atrial Fibrillation 304 304
Wound Dehiscence 301 301
No Patient Involvement 262 262
High Blood Pressure/ Hypertension 260 260
Lactate Dehydrogenase Increased 256 256
Confusion/ Disorientation 252 252
Headache 240 240
Hypervolemia 236 236
Obstruction/Occlusion 236 236
Complaint, Ill-Defined 232 232
Loss of consciousness 232 232
Transient Ischemic Attack 229 229
Fall 221 221
Muscle Weakness 221 221
Hemorrhage, Subarachnoid 215 215
Ischemia Stroke 211 211
Pleural Effusion 210 210
Chest Pain 207 207
Cardiac Tamponade 204 204
Unspecified Nervous System Problem 200 200
Aortic Insufficiency 196 196
Encephalopathy 194 194
Ischemia 192 192
Syncope/Fainting 188 188
Nausea 186 186
Pericardial Effusion 179 179
Ventricular Fibrillation 178 178
Liver Damage/Dysfunction 176 176
Septic Shock 162 162
Vomiting 161 161
Seizures 158 158
Right Ventricular Dysfunction 156 156
Purulent Discharge 151 151
No Information 148 148
Abdominal Pain 138 138
Pneumonia 135 135
Anxiety 133 133
Melena 132 132
Hypoxia 117 117
Dysphasia 113 113
Edema 112 112
Coma 108 108
Hemorrhage, Subdural 107 107
Hypovolemia 107 107
Aortic Valve Insufficiency/ Regurgitation 105 105
Respiratory Distress 104 104
Renal Impairment 98 98
Abscess 94 94
Paralysis 93 93
Embolism 91 91
Fungal Infection 79 79
Pulmonary Edema 78 78

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 Heartware I May-21-2018
3 Heartware I Apr-27-2017
4 Heartware I Apr-25-2017
5 Heartware, Inc. II Sep-16-2021
6 Heartware, Inc. I Aug-06-2021
7 Heartware, Inc. II Jul-13-2021
8 Heartware, Inc. II Apr-21-2021
9 Heartware, Inc. II Apr-20-2021
10 Heartware, Inc. I Apr-16-2021
11 Heartware, Inc. I Apr-06-2021
12 Heartware, Inc. I May-22-2020
13 Heartware, Inc. I Mar-09-2020
14 Heartware, Inc. II Dec-07-2018
15 Heartware, Inc. II Oct-03-2018
16 Jarvik Heart Inc II Dec-18-2018
17 Medtronic Inc I Feb-04-2021
18 Thoratec Corp. II Nov-26-2021
19 Thoratec Corp. II Dec-27-2019
20 Thoratec Corp. II Aug-22-2019
21 Thoratec Corp. II Apr-19-2019
22 Thoratec Corporation I May-24-2017
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