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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
2016 109 109
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 133 133
No Display/Image 91 91
Mechanical Problem 86 86
Infusion or Flow Problem 80 80
Insufficient Information 80 80
Noise, Audible 59 59
Pumping Problem 57 57
Decreased Pump Speed 56 56
Communication or Transmission Problem 49 49
Overheating of Device 46 46
Device Displays Incorrect Message 44 44
Device Stops Intermittently 34 34
Display or Visual Feedback Problem 31 31
Unexpected Shutdown 31 31
Power Problem 28 28
Appropriate Term/Code Not Available 27 27
No Flow 25 25
Electrical /Electronic Property Problem 24 24
Device Operates Differently Than Expected 23 23
Device Operational Issue 22 22
Device Alarm System 22 22
Incorrect, Inadequate or Imprecise Resultor Readings 21 21
Battery Problem 16 16
Vibration 15 15
Insufficient Flow or Under Infusion 15 15
Loss of Power 14 14
Break 14 14
Partial Blockage 13 13
Electrical Power Problem 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Inaccurate Flow Rate 9 9
Smoking 9 9
Detachment of Device or Device Component 8 8
Improper Flow or Infusion 7 7
Mechanical Jam 7 7
Use of Device Problem 7 7
Output Problem 7 7
Temperature Problem 7 7
Unable to Obtain Readings 7 7
Failure to Power Up 7 7
Invalid Sensing 6 6
Connection Problem 6 6
Physical Property Issue 5 5
Excessive Heating 5 5
Visual Prompts will not Clear 5 5
Device Inoperable 5 5
Failure to Run on Battery 5 5
Increased Pump Speed 5 5
Failure to Pump 5 5
Nonstandard Device 5 5
Loose or Intermittent Connection 5 5
Disconnection 4 4
Erratic or Intermittent Display 4 4
No Audible Alarm 4 4
Alarm Not Visible 4 4
Thermal Decomposition of Device 4 4
Failure to Cycle 4 4
Decoupling 4 4
Improper or Incorrect Procedure or Method 4 4
Device Issue 4 4
Maintenance Does Not Comply To Manufacturers Recommendations 4 4
Electrical Shorting 3 3
Device Sensing Problem 3 3
Complete Loss of Power 3 3
Obstruction of Flow 3 3
Failure to Align 3 3
Defective Component 3 3
Failure to Charge 3 3
Image Display Error/Artifact 3 3
Difficult to Insert 2 2
Fracture 2 2
False Alarm 2 2
Failure to Sense 2 2
No Device Output 2 2
No Apparent Adverse Event 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Operating System Becomes Nonfunctional 2 2
Defective Device 2 2
Sparking 2 2
Failure of Device to Self-Test 2 2
Inappropriate or Unexpected Reset 2 2
Device Markings/Labelling Problem 2 2
Improper Device Output 2 2
Material Integrity Problem 2 2
Mechanics Altered 1 1
Naturally Worn 1 1
Material Deformation 1 1
Issue With Displayed Error Message 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Malposition of Device 1 1
Application Program Version or Upgrade Problem 1 1
Calibration Problem 1 1
Charging Problem 1 1
Contamination /Decontamination Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Overstress 1 1
Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 372 372
No Known Impact Or Consequence To Patient 247 247
No Patient Involvement 247 247
No Clinical Signs, Symptoms or Conditions 152 152
Low Blood Pressure/ Hypotension 22 22
Death 18 18
Complaint, Ill-Defined 16 16
Low Oxygen Saturation 14 14
No Information 13 13
Cardiac Arrest 13 13
Insufficient Information 10 10
Thrombus 9 9
Dizziness 6 6
No Code Available 5 5
Hemolysis 5 5
Hemorrhage/Bleeding 4 4
Bradycardia 4 4
Anxiety 4 4
Infarction, Cerebral 4 4
Loss of consciousness 3 3
Neurological Deficit/Dysfunction 3 3
Patient Problem/Medical Problem 3 3
Blood Loss 3 3
Seizures 2 2
Respiratory Failure 2 2
Multiple Organ Failure 2 2
Asystole 2 2
Ventilator Dependent 2 2
Heart Failure 2 2
Cardiogenic Shock 2 2
Coma 1 1
Ventricular Fibrillation 1 1
Cardiovascular Insufficiency 1 1
Hematuria 1 1
Thrombosis 1 1
Pulmonary Edema 1 1
Right Ventricular Failure 1 1
Hypoxia 1 1
Ischemia 1 1
Air Embolism 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Embolus 1 1
Exsanguination 1 1
Hematoma 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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