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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 145 145

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 209 209
Pumping Stopped 206 206
Battery Problem 168 168
Power Problem 155 155
Infusion or Flow Problem 137 137
Device Alarm System 137 137
Mechanical Problem 125 125
No Display/Image 115 115
Pumping Problem 87 87
Other (for use when an appropriate device code cannot be identified) 87 87
Noise, Audible 84 84
Electrical /Electronic Property Problem 67 67
Decreased Pump Speed 66 66
Device Displays Incorrect Message 65 65
Unexpected Shutdown 64 64
Display or Visual Feedback Problem 63 63
Communication or Transmission Problem 56 56
Overheating of Device 54 54
No Flow 38 38
Device Operates Differently Than Expected 37 37
Device Stops Intermittently 35 35
Smoking 30 30
Obstruction of Flow 28 28
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 19 19
No Apparent Adverse Event 18 18
Loss of Power 17 17
Vibration 16 16
Improper or Incorrect Procedure or Method 16 16
Adverse Event Without Identified Device or Use Problem 14 14
Inaccurate Flow Rate 13 13
Partial Blockage 13 13
Material Deformation 11 11
Use of Device Problem 10 10
Detachment of Device or Device Component 10 10
Device Inoperable 10 10
Unable to Obtain Readings 9 9
Excessive Heating 9 9
Loose or Intermittent Connection 8 8
No Audible Alarm 8 8
Mechanical Jam 8 8
Difficult to Open or Close 8 8
Improper Flow or Infusion 8 8
Temperature Problem 8 8
Output Problem 7 7
Connection Problem 7 7
Device Issue 7 7
Invalid Sensing 7 7
Failure to Run on Battery 7 7
Increased Pump Speed 6 6
Failure to Pump 6 6
Nonstandard Device 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
Device Difficult to Setup or Prepare 4 4
Increase in Pressure 4 4
Fracture 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
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 915 915
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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