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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
AMPTD INC.
  SUBSTANTIALLY EQUIVALENT 1
APMTD, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEVITRONIX LLC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 3
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORP
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORPORATION (NOW PART OF ABBOTT)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 98 98
2015 103 103
2016 109 109
2017 140 140
2018 198 198
2019 375 375
2020 146 146
2021 155 155
2022 205 205
2023 438 438
2024 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 205 205
Insufficient Information 202 202
Battery Problem 155 155
Power Problem 148 148
Infusion or Flow Problem 137 137
Device Alarm System 132 132
Mechanical Problem 125 125
No Display/Image 115 115
Other (for use when an appropriate device code cannot be identified) 87 87
Pumping Problem 85 85
Noise, Audible 82 82
Electrical /Electronic Property Problem 66 66
Device Displays Incorrect Message 65 65
Decreased Pump Speed 64 64
Unexpected Shutdown 63 63
Display or Visual Feedback Problem 62 62
Communication or Transmission Problem 56 56
Overheating of Device 54 54
Device Operates Differently Than Expected 37 37
No Flow 37 37
Device Stops Intermittently 35 35
Smoking 30 30
Obstruction of Flow 27 27
Appropriate Term/Code Not Available 27 27
Failure to Power Up 25 25
Break 24 24
Device Operational Issue 24 24
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Insufficient Flow or Under Infusion 19 19
Electrical Power Problem 18 18
Loss of Power 17 17
No Apparent Adverse Event 17 17
Vibration 16 16
Improper or Incorrect Procedure or Method 14 14
Adverse Event Without Identified Device or Use Problem 14 14
Inaccurate Flow Rate 13 13
Partial Blockage 13 13
Material Deformation 11 11
Detachment of Device or Device Component 10 10
Device Inoperable 10 10
Unable to Obtain Readings 9 9
Use of Device Problem 9 9
Excessive Heating 9 9
Mechanical Jam 8 8
Improper Flow or Infusion 8 8
Temperature Problem 8 8
Loose or Intermittent Connection 8 8
No Audible Alarm 8 8
Failure to Run on Battery 7 7
Output Problem 7 7
Difficult to Open or Close 7 7
Device Issue 7 7
Invalid Sensing 7 7
Connection Problem 7 7
Nonstandard Device 6 6
Increased Pump Speed 6 6
Failure to Pump 6 6
Erratic or Intermittent Display 6 6
Disconnection 5 5
Alarm Not Visible 5 5
Thermal Decomposition of Device 5 5
Failure to Charge 5 5
No Device Output 5 5
Visual Prompts will not Clear 5 5
Defective Component 5 5
Physical Property Issue 5 5
Data Problem 5 5
Failure of Device to Self-Test 4 4
Maintenance Does Not Comply To Manufacturers Recommendations 4 4
Device Sensing Problem 4 4
Fracture 4 4
Increase in Pressure 4 4
Failure to Cycle 4 4
Decoupling 4 4
Intermittent Communication Failure 4 4
Complete Loss of Power 4 4
Crack 3 3
Image Display Error/Artifact 3 3
Device Difficult to Setup or Prepare 3 3
Failure to Align 3 3
Calibration Problem 3 3
Improper Device Output 3 3
Electrical Shorting 3 3
Device Dislodged or Dislocated 2 2
Inappropriate or Unexpected Reset 2 2
Material Integrity Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Positioning Problem 2 2
Charging Problem 2 2
Sparking 2 2
Low Battery 2 2
Defective Device 2 2
Device Markings/Labelling Problem 2 2
Excess Flow or Over-Infusion 2 2
Difficult to Insert 2 2
Misconnection 2 2
Material Puncture/Hole 2 2
Self-Activation or Keying 2 2
Failure to Sense 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 873 873
No Consequences Or Impact To Patient 463 463
No Patient Involvement 274 274
No Known Impact Or Consequence To Patient 272 272
No Patient involvement 43 43
Low Blood Pressure/ Hypotension 28 28
Insufficient Information 24 24
Low Oxygen Saturation 20 20
Death 20 20
No Information 18 18
Cardiac Arrest 17 17
Complaint, Ill-Defined 17 17
Thrombus 9 9
Dizziness 6 6
Hemolysis 6 6
No Code Available 6 6
Hemorrhage/Bleeding 5 5
Hypoxia 5 5
Bradycardia 5 5
Loss of consciousness 5 5
Anxiety 4 4
Infarction, Cerebral 4 4
Not Applicable 4 4
Blood Loss 4 4
Patient Problem/Medical Problem 3 3
Neurological Deficit/Dysfunction 3 3
Seizures 2 2
Ventilator Dependent 2 2
Cardiogenic Shock 2 2
Heart Failure 2 2
Air Embolism 2 2
Dyspnea 2 2
Respiratory Failure 2 2
Multiple Organ Failure 2 2
Asystole 2 2
Respiratory Insufficiency 2 2
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cardiovascular Insufficiency 1 1
Syncope/Fainting 1 1
Thrombosis/Thrombus 1 1
Hematuria 1 1
Embolus 1 1
Exsanguination 1 1
Hematoma 1 1
Ischemia 1 1
Bacterial Infection 1 1
Syncope 1 1
Chest Pain 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Hypovolemia 1 1
Coma 1 1
Shock 1 1
Thrombosis 1 1
Ventricular Fibrillation 1 1
Pulmonary Edema 1 1
Rash 1 1
Respiratory Distress 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 Cardiovascular Revascularization & Surgical Therap II Jun-30-2010
6 Medtronic Perfusion Systems I Mar-26-2021
7 Sorin Group Deutschland GmbH II Jan-19-2018
8 Sorin Group Deutschland GmbH II Jan-28-2014
9 Sorin Group Deutschland GmbH II Mar-29-2012
10 Sorin Group USA, Inc. II Oct-29-2012
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