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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
Regulation Description Cardiopulmonary bypass pump speed control.
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

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 120 120
Mechanical Problem 86 86
Insufficient Information 80 80
No Display/Image 78 78
Infusion or Flow Problem 77 77
Noise, Audible 57 57
Pumping Problem 56 56
Decreased Pump Speed 56 56
Communication or Transmission Problem 49 49
Overheating of Device 45 45
Device Displays Incorrect Message 31 31
Unexpected Shutdown 31 31
Display or Visual Feedback Problem 30 30
Power Problem 28 28
Appropriate Term/Code Not Available 27 27
Device Stops Intermittently 24 24
Electrical /Electronic Property Problem 23 23
No Flow 22 22
Device Alarm System 20 20
Incorrect, Inadequate or Imprecise Resultor Readings 17 17
Loss of Power 14 14
Vibration 14 14
Insufficient Flow or Under Infusion 14 14
Battery Problem 13 13
Partial Blockage 13 13
Device Operational Issue 13 13
Device Operates Differently Than Expected 12 12
Break 11 11
Electrical Power Problem 10 10
Inaccurate Flow Rate 9 9
Smoking 8 8
Detachment of Device or Device Component 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Unable to Obtain Readings 7 7
Failure to Power Up 6 6
Use of Device Problem 6 6
Mechanical Jam 6 6
Output Problem 6 6
Temperature Problem 6 6
Connection Problem 6 6
Improper Flow or Infusion 5 5
Physical Property Issue 5 5
Excessive Heating 5 5
Visual Prompts will not Clear 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
Improper or Incorrect Procedure or Method 4 4
Increased Pump Speed 4 4
Failure to Pump 3 3
Obstruction of Flow 3 3
Failure to Align 3 3
Erratic or Intermittent Display 3 3
Failure to Charge 3 3
Image Display Error/Artifact 3 3
Complete Loss of Power 3 3
Device Sensing Problem 3 3
Electrical Shorting 3 3
Failure of Device to Self-Test 2 2
Device Markings/Labelling Problem 2 2
Improper Device Output 2 2
Inappropriate or Unexpected Reset 2 2
Material Integrity Problem 2 2
Operating System Becomes Nonfunctional 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Defective Component 2 2
Defective Device 2 2
Sparking 2 2
Malposition of Device 1 1
Application Program Version or Upgrade Problem 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Invalid Sensing 1 1
Low Battery 1 1
Incorrect Or Inadequate Test Results 1 1
Low Readings 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Sense 1 1
Failure to Read Input Signal 1 1
Electro-Static Discharge 1 1
Unraveled Material 1 1
Tidal Volume Fluctuations 1 1
Air Leak 1 1
Fluid Leak 1 1
Restricted Flow rate 1 1
Difficult to Insert 1 1
Inadequate Instructions for Healthcare Professional 1 1
Misconnection 1 1
Device Emits Odor 1 1
No Device Output 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 327 327
No Known Impact Or Consequence To Patient 240 240
No Patient Involvement 209 209
No Clinical Signs, Symptoms or Conditions 152 152
Low Blood Pressure/ Hypotension 19 19
Death 15 15
Low Oxygen Saturation 13 13
Complaint, Ill-Defined 13 13
Cardiac Arrest 11 11
No Information 10 10
Insufficient Information 10 10
Thrombus 8 8
Dizziness 6 6
No Code Available 5 5
Hemolysis 4 4
Hemorrhage/Bleeding 4 4
Bradycardia 3 3
Infarction, Cerebral 3 3
Anxiety 3 3
Asystole 2 2
Ventilator Dependent 2 2
Patient Problem/Medical Problem 2 2
Seizures 2 2
Neurological Deficit/Dysfunction 2 2
Right Ventricular Failure 1 1
Ischemia 1 1
Thrombosis 1 1
Ventricular Fibrillation 1 1
Air Embolism 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Embolus 1 1
Exsanguination 1 1
Respiratory Failure 1 1
Blood Loss 1 1
Multiple Organ Failure 1 1
Coma 1 1
Loss of consciousness 1 1
Heart Failure 1 1
Cardiogenic Shock 1 1
Cardiovascular Insufficiency 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LivaNova Deutschland GmbH II Jul-08-2020
2 Medtronic Perfusion Systems I Mar-26-2021
3 Sorin Group Deutschland GmbH II Jan-19-2018
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