• 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 3
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 676 676
2019 857 857
2020 627 627
2021 729 729
2022 717 717
2023 814 814
2024 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 700 700
Pumping Stopped 269 269
Pumping Problem 228 228
Display or Visual Feedback Problem 226 226
Device Alarm System 191 191
Mechanical Problem 188 188
Device Displays Incorrect Message 184 184
Failure to Calibrate 168 168
Battery Problem 164 164
Difficult to Open or Close 161 161
Incorrect, Inadequate or Imprecise Result or Readings 144 144
Calibration Problem 134 134
No Display/Image 133 133
Electrical /Electronic Property Problem 111 111
Pressure Problem 103 103
Charging Problem 101 101
Failure to Power Up 83 83
Appropriate Term/Code Not Available 83 83
Break 81 81
Communication or Transmission Problem 80 80
Infusion or Flow Problem 74 74
Device Operates Differently Than Expected 70 70
Power Problem 69 69
Device Sensing Problem 64 64
Failure to Pump 64 64
No Flow 58 58
Inadequate User Interface 51 51
False Alarm 50 50
Failure to Read Input Signal 49 49
Connection Problem 44 44
Inaccurate Flow Rate 32 32
Unexpected Shutdown 32 32
Insufficient Information 31 31
Erratic or Intermittent Display 27 27
Unable to Obtain Readings 27 27
Adverse Event Without Identified Device or Use Problem 26 26
Mechanical Jam 24 24
Noise, Audible 24 24
Use of Device Problem 23 23
Decoupling 23 23
Material Deformation 22 22
Loss of or Failure to Bond 21 21
Out-Of-Box Failure 20 20
Failure to Charge 19 19
Defective Alarm 19 19
Loose or Intermittent Connection 19 19
Loss of Power 19 19
Incorrect Measurement 19 19
Improper Flow or Infusion 19 19
Application Program Freezes, Becomes Nonfunctional 19 19
Fracture 18 18
Protective Measures Problem 14 14
Intermittent Communication Failure 13 13
Detachment of Device or Device Component 13 13
Smoking 12 12
Gas Output Problem 12 12
Leak/Splash 12 12
Increase in Pressure 11 11
Circuit Failure 11 11
Thermal Decomposition of Device 11 11
Defective Component 11 11
Gas/Air Leak 11 11
Device Slipped 10 10
Failure To Adhere Or Bond 10 10
Degraded 10 10
Insufficient Cooling 9 9
Failure to Run on Battery 9 9
No Device Output 9 9
Overheating of Device 9 9
Failure to Auto Stop 9 9
Temperature Problem 9 9
Material Integrity Problem 8 8
Material Twisted/Bent 8 8
Crack 8 8
Failure to Sense 8 8
Increased Pump Speed 7 7
Backflow 7 7
No Pressure 7 7
Electrical Shorting 7 7
Physical Resistance/Sticking 7 7
No Apparent Adverse Event 6 6
Electrical Power Problem 6 6
Corroded 6 6
Contamination 6 6
Material Frayed 6 6
Fluid/Blood Leak 6 6
Decrease in Pressure 6 6
Device Inoperable 6 6
Low Readings 6 6
Unstable 5 5
Fitting Problem 5 5
Decreased Pump Speed 5 5
Display Difficult to Read 5 5
No Audible Alarm 5 5
Inappropriate or Unexpected Reset 5 5
Data Problem 5 5
Material Split, Cut or Torn 4 4
Therapeutic or Diagnostic Output Failure 4 4
No Visual Prompts/Feedback 4 4
Impedance Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2219 2219
No Consequences Or Impact To Patient 1175 1175
No Patient Involvement 749 749
No Known Impact Or Consequence To Patient 265 265
Insufficient Information 199 199
Cardiac Arrest 38 38
Death 35 35
No Information 16 16
Air Embolism 8 8
Low Blood Pressure/ Hypotension 7 7
Low Oxygen Saturation 7 7
Blood Loss 6 6
Hemorrhage/Bleeding 6 6
Brain Injury 4 4
Arrhythmia 4 4
Asystole 4 4
Bronchial Hemorrhage 4 4
Bradycardia 3 3
Not Applicable 3 3
Valvular Stenosis 2 2
Multiple Organ Failure 2 2
Injury 2 2
Ischemia 2 2
Myocarditis 2 2
Burn(s) 2 2
Bacterial Infection 2 2
Airway Obstruction 2 2
Intracranial Hemorrhage 2 2
Exsanguination 2 2
Hematoma 2 2
Respiratory Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hemolytic Anemia 1 1
Hypoxia 1 1
Cardiopulmonary Arrest 1 1
Congenital Defect/Deformity 1 1
Collapse 1 1
Low Cardiac Output 1 1
Nervous System Injury 1 1
Embolism/Embolus 1 1
No Code Available 1 1
Shock from Patient Lead(s) 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 Feb-08-2024
4 Maquet Medical Systems USA II Dec-21-2023
5 Maquet Medical Systems USA II Dec-14-2023
6 Maquet Medical Systems USA I Dec-07-2023
7 Maquet Medical Systems USA II Nov-09-2023
8 Maquet Medical Systems USA II May-26-2023
9 Maquet Medical Systems USA II Apr-08-2022
10 Spectrum Medical Ltd. I Aug-23-2019
11 Terumo Cardiovascular Systems Corporation II Aug-26-2021
12 Terumo Cardiovascular Systems Corporation II Sep-12-2020
13 Terumo Cardiovascular Systems Corporation II Feb-07-2020
14 Terumo Cardiovascular Systems Corporation II Jun-11-2019
15 Terumo Cardiovascular Systems Corporation II May-15-2019
16 Terumo Cardiovascular Systems Corporation II Oct-18-2018
17 Terumo Cardiovascular Systems Corporation II Sep-25-2018
18 Terumo Cardiovascular Systems Corporation II Apr-20-2018
-
-