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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
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORPORATION (NOW PART OF ABBOTT)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 140 140
2018 198 198
2019 376 376
2020 146 146
2021 155 155
2022 169 169

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 141 141
Insufficient Information 112 112
Mechanical Problem 97 97
Infusion or Flow Problem 93 93
No Display/Image 84 84
Pumping Problem 62 62
Noise, Audible 62 62
Decreased Pump Speed 60 60
Communication or Transmission Problem 50 50
Power Problem 47 47
Overheating of Device 47 47
Unexpected Shutdown 44 44
Display or Visual Feedback Problem 39 39
Electrical /Electronic Property Problem 33 33
Device Alarm System 33 33
Device Displays Incorrect Message 31 31
Battery Problem 30 30
Appropriate Term/Code Not Available 27 27
No Flow 24 24
Device Stops Intermittently 24 24
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Electrical Power Problem 15 15
Loss of Power 14 14
Smoking 14 14
Vibration 14 14
Insufficient Flow or Under Infusion 14 14
Partial Blockage 13 13
Device Operational Issue 13 13
Device Operates Differently Than Expected 12 12
Break 12 12
Inaccurate Flow Rate 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Obstruction of Flow 9 9
Improper or Incorrect Procedure or Method 8 8
Failure to Power Up 8 8
Detachment of Device or Device Component 8 8
Connection Problem 7 7
Mechanical Jam 7 7
Excessive Heating 7 7
Unable to Obtain Readings 7 7
Use of Device Problem 6 6
No Apparent Adverse Event 6 6
Output Problem 6 6
Temperature Problem 6 6
Physical Property Issue 5 5
Improper Flow or Infusion 5 5
Visual Prompts will not Clear 5 5
Increased Pump Speed 5 5
Loose or Intermittent Connection 5 5
Device Inoperable 5 5
Failure to Run on Battery 5 5
Nonstandard Device 5 5
Thermal Decomposition of Device 4 4
No Audible Alarm 4 4
Alarm Not Visible 4 4
Failure to Cycle 4 4
Decoupling 4 4
Disconnection 4 4
Failure to Pump 4 4
Data Problem 4 4
Complete Loss of Power 3 3
Device Sensing Problem 3 3
Electrical Shorting 3 3
Device Difficult to Setup or Prepare 3 3
Failure to Align 3 3
Erratic or Intermittent Display 3 3
Failure to Charge 3 3
Image Display Error/Artifact 3 3
Misconnection 2 2
Fracture 2 2
Sparking 2 2
Defective Component 2 2
Failure to Read Input Signal 2 2
Failure of Device to Self-Test 2 2
Inappropriate or Unexpected Reset 2 2
Device Markings/Labelling Problem 2 2
Defective Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Operating System Becomes Nonfunctional 2 2
Improper Device Output 2 2
Material Integrity Problem 2 2
Issue With Displayed Error Message 1 1
Material Deformation 1 1
Mechanics Altered 1 1
Misassembly by Users 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Compatibility Problem 1 1
Electrical Overstress 1 1
Human-Device Interface Problem 1 1
Intermittent Loss of Power 1 1
Unintended Electrical Shock 1 1
Wireless Communication Problem 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 327 327
No Clinical Signs, Symptoms or Conditions 315 315
No Known Impact Or Consequence To Patient 240 240
No Patient Involvement 209 209
Low Blood Pressure/ Hypotension 21 21
Insufficient Information 16 16
Death 15 15
Low Oxygen Saturation 15 15
Complaint, Ill-Defined 13 13
Cardiac Arrest 12 12
No Information 10 10
Thrombus 8 8
Dizziness 6 6
No Code Available 5 5
Bradycardia 4 4
Hemolysis 4 4
Hemorrhage/Bleeding 4 4
Infarction, Cerebral 3 3
Anxiety 3 3
Loss of consciousness 3 3
Patient Problem/Medical Problem 2 2
Asystole 2 2
Ventilator Dependent 2 2
Neurological Deficit/Dysfunction 2 2
Seizures 2 2
Thrombosis 1 1
Right Ventricular Failure 1 1
Hypoxia 1 1
Ischemia 1 1
Chest Pain 1 1
Embolus 1 1
Exsanguination 1 1
Air Embolism 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Coma 1 1
Respiratory Failure 1 1
Blood Loss 1 1
Multiple Organ Failure 1 1
Syncope/Fainting 1 1
Thrombosis/Thrombus 1 1
Ventricular Fibrillation 1 1
Heart Failure 1 1
Hypovolemia 1 1
Cardiogenic Shock 1 1
Cardiovascular Insufficiency 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Assist, Inc I Sep-23-2022
2 LivaNova Deutschland GmbH III Mar-15-2022
3 LivaNova Deutschland GmbH II Jul-08-2020
4 Medtronic Perfusion Systems I Mar-26-2021
5 Sorin Group Deutschland GmbH II Jan-19-2018
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