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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 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 131 131
No Display/Image 91 91
Mechanical Problem 83 83
Insufficient Information 75 75
Infusion or Flow Problem 74 74
Noise, Audible 59 59
Decreased Pump Speed 55 55
Pumping Problem 54 54
Communication or Transmission Problem 46 46
Overheating of Device 46 46
Device Displays Incorrect Message 44 44
Device Stops Intermittently 34 34
Display or Visual Feedback Problem 29 29
Power Problem 28 28
Appropriate Term/Code Not Available 27 27
Unexpected Shutdown 26 26
No Flow 25 25
Device Operates Differently Than Expected 23 23
Electrical /Electronic Property Problem 23 23
Device Operational Issue 22 22
Incorrect, Inadequate or Imprecise Resultor Readings 21 21
Device Alarm System 21 21
Vibration 15 15
Insufficient Flow or Under Infusion 15 15
Loss of Power 14 14
Break 14 14
Battery Problem 13 13
Partial Blockage 13 13
Inaccurate Flow Rate 9 9
Electrical Power Problem 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Smoking 9 9
Detachment of Device or Device Component 8 8
Mechanical Jam 7 7
Improper Flow or Infusion 7 7
Output Problem 7 7
Temperature Problem 7 7
Use of Device Problem 7 7
Failure to Power Up 6 6
Connection Problem 6 6
Invalid Sensing 6 6
Unable to Obtain Readings 6 6
Loose or Intermittent Connection 5 5
Device Inoperable 5 5
Failure to Run on Battery 5 5
Excessive Heating 5 5
Visual Prompts will not Clear 5 5
Increased Pump Speed 5 5
Failure to Pump 5 5
Physical Property Issue 5 5
Maintenance Does Not Comply To Manufacturers Recommendations 4 4
Device Issue 4 4
Failure to Cycle 4 4
Decoupling 4 4
Disconnection 4 4
Erratic or Intermittent Display 4 4
Thermal Decomposition of Device 4 4
Alarm Not Visible 4 4
Image Display Error/Artifact 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Component 3 3
Complete Loss of Power 3 3
Device Sensing Problem 3 3
Electrical Shorting 3 3
Failure to Charge 3 3
Nonstandard Device 3 3
Failure to Align 3 3
Obstruction of Flow 3 3
No Device Output 2 2
Operating System Becomes Nonfunctional 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Defective Device 2 2
Sparking 2 2
Failure to Sense 2 2
No Audible Alarm 2 2
Fracture 2 2
Failure of Device to Self-Test 2 2
Improper Device Output 2 2
Inappropriate or Unexpected Reset 2 2
Device Markings/Labelling Problem 2 2
Material Integrity Problem 2 2
Positioning Problem 2 2
Difficult to Insert 2 2
False Alarm 2 2
Defective Alarm 1 1
Premature Discharge of Battery 1 1
Circuit Failure 1 1
Computer Software Problem 1 1
Restricted Flow rate 1 1
Difficult or Delayed Positioning 1 1
Material Discolored 1 1
Low Readings 1 1
Low Battery 1 1
Charging Problem 1 1
Contamination /Decontamination Problem 1 1
Malposition of Device 1 1
Electro-Static Discharge 1 1
Unraveled Material 1 1
Misconnection 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 126 126
Low Blood Pressure/ Hypotension 22 22
Death 18 18
Complaint, Ill-Defined 16 16
No Information 13 13
Cardiac Arrest 12 12
Low Oxygen Saturation 12 12
Thrombus 9 9
Insufficient Information 7 7
Dizziness 6 6
Hemolysis 5 5
No Code Available 5 5
Anxiety 4 4
Hemorrhage/Bleeding 4 4
Bradycardia 4 4
Infarction, Cerebral 4 4
Blood Loss 3 3
Patient Problem/Medical Problem 3 3
Loss of consciousness 3 3
Neurological Deficit/Dysfunction 3 3
Respiratory Failure 2 2
Multiple Organ Failure 2 2
Asystole 2 2
Heart Failure 2 2
Cardiogenic Shock 2 2
Ventilator Dependent 2 2
Seizures 2 2
Ventricular Fibrillation 1 1
Embolus 1 1
Stroke/CVA 1 1
Hypoxia 1 1
Pulmonary Edema 1 1
Right Ventricular Failure 1 1
Cardiovascular Insufficiency 1 1
Hematuria 1 1
Thrombosis 1 1
Air Embolism 1 1
Cardiopulmonary Arrest 1 1
Hematoma 1 1
Coma 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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