• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device ventricular (assist) bypass
Definition Approved pma: P870072
Product CodeDSQ
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
37 36 35 34 48 28

MDR Year MDR Reports MDR Events
2016 7187 7187
2017 9055 9055
2018 12660 12660
2019 20216 20216
2020 14238 14238
2021 11600 11600

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36114 36114
Battery Problem 5586 5586
Power Problem 5092 5092
Pumping Problem 4952 4952
Break 3207 3207
Connection Problem 2810 2810
Infusion or Flow Problem 2775 2775
Pumping Stopped 2508 2508
Mechanical Problem 2462 2462
Material Integrity Problem 1680 1680
Device Stops Intermittently 1483 1483
Obstruction of Flow 1430 1430
Loose or Intermittent Connection 1262 1262
High Readings 1052 1052
Decreased Pump Speed 977 977
Material Twisted/Bent 949 949
Electrical /Electronic Property Problem 924 924
Disconnection 905 905
Electrical Power Problem 782 782
Material Split, Cut or Torn 779 779
Complete Loss of Power 736 736
Insufficient Information 722 722
Material Deformation 608 608
Device Displays Incorrect Message 494 494
Use of Device Problem 442 442
Communication or Transmission Problem 318 318
Loss of Power 312 312
Device Alarm System 309 309
No Audible Alarm 297 297
Malposition of Device 286 286
Electrical Shorting 278 278
Appropriate Term/Code Not Available 260 260
Display or Visual Feedback Problem 247 247
Naturally Worn 229 229
Partial Blockage 226 226
Output Problem 218 218
Overheating of Device 211 211
Noise, Audible 199 199
Protective Measures Problem 194 194
Restricted Flow rate 186 186
No Apparent Adverse Event 168 168
No Display/Image 162 162
Increase in Suction 158 158
Data Problem 151 151
Device Difficult to Setup or Prepare 144 144
Contamination 130 130
Date/Time-Related Software Problem 126 126
Device Inoperable 124 124
Leak/Splash 115 115
Device Operates Differently Than Expected 113 113
Device Contamination with Chemical or Other Material 111 111
Crack 108 108
Insufficient Flow or Under Infusion 91 91
Failure to Pump 90 90
Kinked 88 88
Failure to Charge 87 87
Improper or Incorrect Procedure or Method 85 85
Low Readings 75 75
Low Audible Alarm 67 67
Torn Material 65 65
Failure to Power Up 63 63
Occlusion Within Device 63 63
Fracture 62 62
Detachment of Device or Device Component 60 60
Incomplete or Inadequate Connection 60 60
Image Display Error/Artifact 59 59
Bent 58 58
Fluid Leak 57 57
Cut In Material 52 52
Migration or Expulsion of Device 52 52
Improper Flow or Infusion 50 50
Deformation Due to Compressive Stress 50 50
Device Fell 47 47
Alarm Not Visible 45 45
Vibration 44 44
Electro-Static Discharge 40 40
Material Separation 40 40
Maintenance Does Not Comply To Manufacturers Recommendations 37 37
Contamination /Decontamination Problem 35 35
Failure to Align 34 34
Electromagnetic Interference 34 34
Material Discolored 32 32
Difficult to Remove 31 31
Moisture Damage 30 30
Fitting Problem 29 29
Premature Discharge of Battery 28 28
Detachment Of Device Component 28 28
Device Damaged Prior to Use 27 27
Charging Problem 27 27
Increased Pump Speed 27 27
Microbial Contamination of Device 26 26
Component Missing 25 25
Material Protrusion/Extrusion 24 24
Therapeutic or Diagnostic Output Failure 22 22
Corroded 22 22
Poor Quality Image 21 21
Device Misassembled During Manufacturing /Shipping 21 21
No Flow 21 21
Unintended Electrical Shock 20 20
Nonstandard Device 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14964 14965
No Consequences Or Impact To Patient 9659 9659
Blood Loss 9388 9389
Death 6872 6872
No Clinical Signs, Symptoms or Conditions 6137 6137
Unspecified Infection 6066 6066
Thrombus 5258 5258
Hemolysis 3882 3883
Stroke/CVA 2563 2563
Bacterial Infection 2097 2097
Neurological Deficit/Dysfunction 1704 1704
Sepsis 1636 1636
Hemorrhage, Cerebral 1529 1529
Hemorrhage/Bleeding 1395 1395
Renal Failure 1317 1317
Arrhythmia 1221 1221
Respiratory Failure 1215 1215
Heart Failure 1174 1174
Thrombosis/Thrombus 1080 1080
Anemia 983 983
Infarction, Cerebral 932 932
Thrombosis 807 807
Post Operative Wound Infection 785 785
Multiple Organ Failure 771 771
Hematuria 768 769
Heart Failure/Congestive Heart Failure 744 744
Insufficient Information 741 741
Right Ventricular Failure 703 703
Dyspnea 699 699
No Code Available 655 655
Dizziness 652 652
Gastrointestinal Hemorrhage 629 629
Weakness 507 507
Thromboembolism 494 494
Intracranial Hemorrhage 478 479
Fatigue 469 469
Fever 439 439
Ventricular Tachycardia 433 433
Skin Infection 398 398
Cardiac Arrest 395 395
Syncope 391 391
Complaint, Ill-Defined 369 369
Hematoma 360 360
Pain 337 337
Low Blood Pressure/ Hypotension 321 321
Cardiogenic Shock 296 296
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 286 286
Wound Dehiscence 281 281
Tachycardia 270 270
No Patient Involvement 267 267
Hemorrhagic Stroke 254 254
Loss of consciousness 249 249
Atrial Fibrillation 244 244
High Blood Pressure/ Hypertension 243 243
Hemorrhage, Subarachnoid 242 242
Confusion/ Disorientation 240 240
Headache 237 237
Hypervolemia 229 229
Transient Ischemic Attack 229 229
Fall 223 223
Chest Pain 216 216
Obstruction/Occlusion 207 207
Aortic Insufficiency 207 207
Lactate Dehydrogenase Increased 203 203
Pleural Effusion 198 198
No Information 195 195
Cardiac Tamponade 195 195
Ischemia 193 193
Nausea 192 192
Muscle Weakness 183 183
Liver Damage/Dysfunction 174 174
Encephalopathy 173 173
Pericardial Effusion 171 171
Ventricular Fibrillation 169 169
Seizures 165 165
Right Ventricular Dysfunction 162 162
Vomiting 161 161
Anxiety 160 160
Ischemia Stroke 152 152
Septic Shock 151 151
Syncope/Fainting 147 147
Purulent Discharge 145 145
Abdominal Pain 140 140
Unspecified Nervous System Problem 133 133
Edema 126 126
Hemorrhage, Subdural 126 126
Respiratory Distress 121 121
Hypovolemia 116 116
Dysphasia 114 114
Pneumonia 112 112
Melena 110 110
Hypoxia 109 109
Coma 102 102
Abscess 95 95
Embolism 95 95
Paralysis 87 87
Erythema 79 79
Cardiopulmonary Arrest 77 77
Pulmonary Edema 77 77
Fungal Infection 74 74

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 HeartWare, Inc I Oct-13-2016
3 Heartware I May-21-2018
4 Heartware I Apr-27-2017
5 Heartware I Apr-25-2017
6 Heartware, Inc. II Sep-16-2021
7 Heartware, Inc. I Aug-06-2021
8 Heartware, Inc. II Jul-13-2021
9 Heartware, Inc. II Apr-21-2021
10 Heartware, Inc. II Apr-20-2021
11 Heartware, Inc. I Apr-16-2021
12 Heartware, Inc. I Apr-06-2021
13 Heartware, Inc. I May-22-2020
14 Heartware, Inc. I Mar-09-2020
15 Heartware, Inc. II Dec-07-2018
16 Heartware, Inc. II Oct-03-2018
17 Heartware, Inc. I Oct-17-2016
18 Heartware, Inc. I Jul-08-2016
19 Jarvik Heart Inc II Dec-18-2018
20 Medtronic Inc I Feb-04-2021
21 Thoratec Corp. II Dec-27-2019
22 Thoratec Corp. II Aug-22-2019
23 Thoratec Corp. II Apr-19-2019
24 Thoratec Corporation I May-24-2017
-
-