Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
THORATEC CORPORATION (NOW PART OF ABBOTT)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 198 198
2019 376 376
2020 146 146
2021 155 155
2022 205 205
2023 128 128

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 149 149
Pumping Stopped 143 143
Mechanical Problem 103 103
Infusion or Flow Problem 95 95
Power Problem 74 74
Pumping Problem 64 64
Noise, Audible 64 64
No Display/Image 63 63
Device Alarm System 61 61
Battery Problem 61 61
Decreased Pump Speed 59 59
Communication or Transmission Problem 54 54
Unexpected Shutdown 53 53
Overheating of Device 48 48
Display or Visual Feedback Problem 44 44
Electrical /Electronic Property Problem 37 37
Appropriate Term/Code Not Available 27 27
No Flow 19 19
Obstruction of Flow 15 15
Smoking 14 14
Electrical Power Problem 14 14
Vibration 13 13
Partial Blockage 13 13
Insufficient Flow or Under Infusion 12 12
Device Stops Intermittently 11 11
Break 11 11
Failure to Power Up 11 11
No Apparent Adverse Event 11 11
Device Displays Incorrect Message 10 10
Loss of Power 9 9
Detachment of Device or Device Component 8 8
Improper or Incorrect Procedure or Method 8 8
Unable to Obtain Readings 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Excessive Heating 8 8
Mechanical Jam 7 7
Connection Problem 7 7
Inaccurate Flow Rate 7 7
Use of Device Problem 6 6
Temperature Problem 6 6
Data Problem 5 5
Material Deformation 5 5
Improper Flow or Infusion 5 5
Visual Prompts will not Clear 5 5
Increased Pump Speed 5 5
Loose or Intermittent Connection 5 5
Failure to Run on Battery 5 5
Nonstandard Device 5 5
Disconnection 5 5
Failure to Cycle 4 4
Decoupling 4 4
No Audible Alarm 4 4
Defective Component 4 4
Difficult to Open or Close 4 4
Electrical Shorting 3 3
Failure of Device to Self-Test 3 3
Complete Loss of Power 3 3
Output Problem 3 3
Failure to Pump 3 3
Device Sensing Problem 3 3
Device Operates Differently Than Expected 3 3
Failure to Align 3 3
Alarm Not Visible 3 3
Thermal Decomposition of Device 3 3
Erratic or Intermittent Display 3 3
Device Difficult to Setup or Prepare 3 3
Misconnection 2 2
Fracture 2 2
Image Display Error/Artifact 2 2
Failure to Charge 2 2
Defective Device 2 2
Sparking 2 2
Device Markings/Labelling Problem 2 2
Failure to Read Input Signal 2 2
Therapeutic or Diagnostic Output Failure 2 2
Misassembly by Users 1 1
Pressure Problem 1 1
Intermittent Loss of Power 1 1
Unintended Electrical Shock 1 1
Wireless Communication Problem 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Improper Device Output 1 1
Electrical Overstress 1 1
Compatibility Problem 1 1
Material Integrity Problem 1 1
Issue With Displayed Error Message 1 1
Mechanics Altered 1 1
Operating System Becomes Nonfunctional 1 1
Incomplete or Inadequate Connection 1 1
No Tactile Prompts/Feedback 1 1
Low Readings 1 1
Material Puncture/Hole 1 1
Tidal Volume Fluctuations 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Operational Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 468 468
No Consequences Or Impact To Patient 256 256
No Known Impact Or Consequence To Patient 225 225
No Patient Involvement 172 172
Insufficient Information 22 22
Low Oxygen Saturation 17 17
Low Blood Pressure/ Hypotension 14 14
Death 12 12
Cardiac Arrest 11 11
Complaint, Ill-Defined 11 11
No Information 9 9
Thrombus 6 6
Dizziness 6 6
Bradycardia 4 4
No Code Available 4 4
Hemorrhage/Bleeding 4 4
Anxiety 3 3
Loss of consciousness 3 3
Hemolysis 3 3
Hypoxia 3 3
Dyspnea 3 3
Infarction, Cerebral 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
Respiratory Failure 1 1
Blood Loss 1 1
Multiple Organ Failure 1 1
Syncope/Fainting 1 1
Thrombosis/Thrombus 1 1
Heart Failure 1 1
Hypovolemia 1 1
Cardiogenic Shock 1 1
Chest Pain 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Embolus 1 1
Exsanguination 1 1
Ischemia 1 1
Neurological Deficit/Dysfunction 1 1
Right Ventricular Failure 1 1
Thrombosis 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 Perfusion Systems I Mar-26-2021
6 Sorin Group Deutschland GmbH II Jan-19-2018
-
-