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 console, heart-lung machine, cardiopulmonary bypass
Product CodeDTQ
Regulation Number 870.4220
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTURY HLM, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 676 676
2019 857 857
2020 627 627
2021 729 729
2022 720 720
2023 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 618 618
Device Displays Incorrect Message 184 184
Pumping Problem 180 180
Pumping Stopped 167 167
Display or Visual Feedback Problem 163 163
Device Alarm System 162 162
Mechanical Problem 154 154
Battery Problem 152 152
Difficult to Open or Close 134 134
No Display/Image 125 125
Failure to Calibrate 117 117
Incorrect, Inadequate or Imprecise Result or Readings 112 112
Calibration Problem 106 106
Charging Problem 93 93
Appropriate Term/Code Not Available 83 83
Failure to Power Up 76 76
Electrical /Electronic Property Problem 76 76
Device Operates Differently Than Expected 70 70
Break 69 69
Failure to Pump 61 61
Communication or Transmission Problem 60 60
Pressure Problem 60 60
Device Sensing Problem 58 58
Infusion or Flow Problem 56 56
No Flow 55 55
Power Problem 54 54
False Alarm 44 44
Inadequate User Interface 42 42
Connection Problem 39 39
Inaccurate Flow Rate 30 30
Unexpected Shutdown 29 29
Erratic or Intermittent Display 27 27
Unable to Obtain Readings 24 24
Use of Device Problem 22 22
Loss of or Failure to Bond 21 21
Out-Of-Box Failure 20 20
Noise, Audible 20 20
Mechanical Jam 20 20
Adverse Event Without Identified Device or Use Problem 20 20
Application Program Freezes, Becomes Nonfunctional 19 19
Loss of Power 19 19
Incorrect Measurement 18 18
Failure to Charge 18 18
Improper Flow or Infusion 18 18
Material Deformation 18 18
Loose or Intermittent Connection 17 17
Fracture 17 17
Defective Alarm 16 16
Decoupling 16 16
Protective Measures Problem 14 14
Insufficient Information 12 12
Gas Output Problem 12 12
Detachment of Device or Device Component 12 12
Defective Component 11 11
Leak/Splash 11 11
Thermal Decomposition of Device 11 11
Gas/Air Leak 11 11
Circuit Failure 10 10
Failure To Adhere Or Bond 10 10
Degraded 10 10
Device Slipped 10 10
Smoking 10 10
Failure to Run on Battery 9 9
No Device Output 8 8
Overheating of Device 8 8
Failure to Sense 8 8
Failure to Read Input Signal 8 8
Material Twisted/Bent 8 8
Material Integrity Problem 7 7
Failure to Auto Stop 7 7
Temperature Problem 7 7
Physical Resistance/Sticking 7 7
Increased Pump Speed 7 7
Electrical Shorting 7 7
Increase in Pressure 7 7
Backflow 7 7
Contamination 6 6
Fluid/Blood Leak 6 6
Device Inoperable 6 6
Intermittent Communication Failure 6 6
Electrical Power Problem 6 6
Inappropriate or Unexpected Reset 5 5
Material Frayed 5 5
Decreased Pump Speed 5 5
No Audible Alarm 5 5
Computer Software Problem 4 4
Corroded 4 4
Positioning Failure 4 4
Display Difficult to Read 4 4
Misconnection 4 4
Unstable 4 4
Device Damaged Prior to Use 4 4
Defective Device 4 4
High Readings 4 4
Impedance Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 3 3
No Apparent Adverse Event 3 3
No Pressure 3 3
Activation Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1537 1537
No Consequences Or Impact To Patient 1175 1175
No Patient Involvement 749 749
No Known Impact Or Consequence To Patient 265 265
Insufficient Information 119 119
Death 35 35
Cardiac Arrest 29 29
No Information 16 16
Air Embolism 7 7
Low Blood Pressure/ Hypotension 6 6
Blood Loss 6 6
Hemorrhage/Bleeding 4 4
Low Oxygen Saturation 4 4
Not Applicable 3 3
Respiratory Arrest 2 2
Injury 2 2
Airway Obstruction 2 2
Arrhythmia 2 2
Exsanguination 2 2
Hematoma 2 2
Cardiopulmonary Arrest 1 1
Congenital Defect/Deformity 1 1
Bradycardia 1 1
Collapse 1 1
Low Cardiac Output 1 1
Hypoxia 1 1
Brain Injury 1 1
Hemolytic Anemia 1 1
No Code Available 1 1
Shock from Patient Lead(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LivaNova USA Inc. III Feb-10-2020
2 Maquet Cardiovascular Us Sales, Llc I Mar-28-2019
3 Maquet Medical Systems USA II Apr-08-2022
4 Spectrum Medical Ltd. I Aug-23-2019
5 Terumo Cardiovascular Systems Corporation II Aug-26-2021
6 Terumo Cardiovascular Systems Corporation II Sep-12-2020
7 Terumo Cardiovascular Systems Corporation II Feb-07-2020
8 Terumo Cardiovascular Systems Corporation II Jun-11-2019
9 Terumo Cardiovascular Systems Corporation II May-15-2019
10 Terumo Cardiovascular Systems Corporation II Oct-18-2018
11 Terumo Cardiovascular Systems Corporation II Sep-25-2018
12 Terumo Cardiovascular Systems Corporation II Apr-20-2018
-
-