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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
INSPIRA TECHNOLOGIES OXY B.H.N LTD.
  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 174 174

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 221 221
Pumping Stopped 208 208
Battery Problem 172 172
Power Problem 158 158
Infusion or Flow Problem 138 138
Device Alarm System 138 138
Mechanical Problem 125 125
No Display/Image 116 116
Pumping Problem 87 87
Other (for use when an appropriate device code cannot be identified) 87 87
Noise, Audible 87 87
Electrical /Electronic Property Problem 68 68
Decreased Pump Speed 66 66
Unexpected Shutdown 66 66
Device Displays Incorrect Message 65 65
Display or Visual Feedback Problem 64 64
Overheating of Device 56 56
Communication or Transmission Problem 56 56
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 21 21
Electrical Power Problem 20 20
No Apparent Adverse Event 20 20
Loss of Power 17 17
Vibration 16 16
Improper or Incorrect Procedure or Method 16 16
Adverse Event Without Identified Device or Use Problem 15 15
Partial Blockage 13 13
Inaccurate Flow Rate 13 13
Material Deformation 12 12
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
Difficult to Open or Close 8 8
Mechanical Jam 8 8
Improper Flow or Infusion 8 8
Temperature Problem 8 8
Output Problem 7 7
Device Issue 7 7
Connection Problem 7 7
Invalid Sensing 7 7
Failure to Run on Battery 7 7
Nonstandard Device 6 6
Increased Pump Speed 6 6
Failure to Pump 6 6
Failure to Charge 6 6
Erratic or Intermittent Display 6 6
Disconnection 5 5
Thermal Decomposition of Device 5 5
Alarm Not Visible 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
Maintenance Does Not Comply To Manufacturers Recommendations 4 4
Failure of Device to Self-Test 4 4
Device Sensing Problem 4 4
Device Difficult to Setup or Prepare 4 4
Increase in Pressure 4 4
Failure to Cycle 4 4
Decoupling 4 4
Fracture 4 4
Intermittent Communication Failure 4 4
Complete Loss of Power 4 4
Crack 3 3
Image Display Error/Artifact 3 3
Calibration Problem 3 3
Failure to Align 3 3
Electrical Shorting 3 3
Improper Device Output 3 3
Inappropriate or Unexpected Reset 2 2
Material Integrity Problem 2 2
Operating System Becomes Nonfunctional 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Low Battery 2 2
Defective Device 2 2
Charging Problem 2 2
Sparking 2 2
Device Dislodged or Dislocated 2 2
Device Markings/Labelling Problem 2 2
Excess Flow or Over-Infusion 2 2
Difficult to Insert 2 2
Failure to Interrogate 2 2
Misconnection 2 2
Self-Activation or Keying 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 939 939
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 26 26
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
Loss of consciousness 5 5
Hemorrhage/Bleeding 5 5
Hypoxia 5 5
Bradycardia 5 5
Infarction, Cerebral 4 4
Anxiety 4 4
Blood Loss 4 4
Not Applicable 4 4
Patient Problem/Medical Problem 3 3
Respiratory Insufficiency 3 3
Stroke/CVA 3 3
Neurological Deficit/Dysfunction 3 3
Seizures 2 2
Heart Failure 2 2
Cardiogenic Shock 2 2
Ventilator Dependent 2 2
Air Embolism 2 2
Dyspnea 2 2
Asystole 2 2
Multiple Organ Failure 2 2
Respiratory Failure 2 2
Hematuria 1 1
Syncope/Fainting 1 1
Thrombosis/Thrombus 1 1
Cardiovascular Insufficiency 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
Coma 1 1
Hypovolemia 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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