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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device control, pump speed, cardiopulmonary bypass
Product CodeDWA
Regulation Number 870.4380
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT (FORMERLY THORATEC CORPORATION)
  SUBSTANTIALLY EQUIVALENT 1
APMTD INC.
  SUBSTANTIALLY EQUIVALENT 1
APMTD, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSPIRA TECHNOLOGIES OXY B.H.N LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORPORATION (NOW PART OF ABBOTT)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 375 375
2020 146 146
2021 155 155
2022 205 205
2023 439 439
2024 299 299

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 242 242
Battery Problem 191 191
Power Problem 158 158
Device Alarm System 152 152
Pumping Stopped 149 149
Infusion or Flow Problem 134 134
Pumping Problem 84 84
Unexpected Shutdown 73 73
Noise, Audible 68 68
Mechanical Problem 68 68
Display or Visual Feedback Problem 67 67
Electrical /Electronic Property Problem 66 66
Communication or Transmission Problem 56 56
Decreased Pump Speed 52 52
Overheating of Device 45 45
No Display/Image 41 41
Obstruction of Flow 30 30
Failure to Power Up 24 24
No Apparent Adverse Event 24 24
Smoking 23 23
No Flow 22 22
Appropriate Term/Code Not Available 22 22
Electrical Power Problem 18 18
Material Deformation 16 16
Improper or Incorrect Procedure or Method 14 14
Insufficient Flow or Under Infusion 14 14
Vibration 13 13
Partial Blockage 13 13
Adverse Event Without Identified Device or Use Problem 11 11
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Detachment of Device or Device Component 10 10
Excessive Heating 9 9
Connection Problem 9 9
Break 9 9
Difficult to Open or Close 8 8
Mechanical Jam 7 7
No Audible Alarm 7 7
Unable to Obtain Readings 7 7
Nonstandard Device 6 6
Loss of Power 6 6
Alarm Not Visible 6 6
Increased Pump Speed 6 6
Disconnection 6 6
Increase in Pressure 5 5
Data Problem 5 5
Failure of Device to Self-Test 5 5
Complete Loss of Power 5 5
Device Difficult to Setup or Prepare 5 5
Failure to Run on Battery 5 5
Temperature Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1068 1068
No Consequences Or Impact To Patient 195 195
No Known Impact Or Consequence To Patient 150 150
No Patient Involvement 139 139
Insufficient Information 26 26
Low Oxygen Saturation 16 16
Cardiac Arrest 13 13
Death 12 12
Low Blood Pressure/ Hypotension 10 10
No Information 8 8
Thrombus 6 6
Hemorrhage/Bleeding 4 4
Hypoxia 4 4
Stroke/CVA 3 3
Respiratory Insufficiency 3 3
Hemolysis 3 3
No Code Available 3 3
Loss of consciousness 3 3
Dyspnea 3 3
Asystole 2 2
Bradycardia 2 2
Infarction, Cerebral 2 2
Cardiogenic Shock 1 1
Chest Pain 1 1
Cardiopulmonary Arrest 1 1
Thrombosis/Thrombus 1 1
Respiratory Acidosis 1 1
Shock 1 1
Anxiety 1 1
Cough 1 1
Unspecified Tissue Injury 1 1
Multiple Organ Failure 1 1
Cardiovascular Insufficiency 1 1
Blood Loss 1 1
Ischemia 1 1
Exsanguination 1 1
Complaint, Ill-Defined 1 1
Bacterial Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Syncope/Fainting 1 1
Hypovolemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Assist, Inc I Jan-19-2023
2 Cardiac Assist, Inc I Sep-23-2022
3 LivaNova Deutschland GmbH III Mar-15-2022
4 LivaNova Deutschland GmbH II Jul-08-2020
5 Medtronic Perfusion Systems I Mar-26-2021
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