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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 761 761

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 683 683
Pumping Stopped 249 249
Pumping Problem 221 221
Display or Visual Feedback Problem 216 216
Device Displays Incorrect Message 184 184
Device Alarm System 183 183
Mechanical Problem 183 183
Battery Problem 163 163
Failure to Calibrate 162 162
Difficult to Open or Close 155 155
Incorrect, Inadequate or Imprecise Result or Readings 141 141
No Display/Image 132 132
Calibration Problem 128 128
Electrical /Electronic Property Problem 104 104
Charging Problem 100 100
Pressure Problem 91 91
Appropriate Term/Code Not Available 83 83
Failure to Power Up 82 82
Break 78 78
Communication or Transmission Problem 78 78
Device Operates Differently Than Expected 70 70
Infusion or Flow Problem 70 70
Power Problem 69 69
Device Sensing Problem 64 64
Failure to Pump 64 64
No Flow 58 58
Inadequate User Interface 49 49
False Alarm 46 46
Connection Problem 44 44
Failure to Read Input Signal 38 38
Inaccurate Flow Rate 32 32
Unexpected Shutdown 31 31
Insufficient Information 29 29
Erratic or Intermittent Display 27 27
Unable to Obtain Readings 27 27
Adverse Event Without Identified Device or Use Problem 26 26
Noise, Audible 24 24
Decoupling 23 23
Use of Device Problem 22 22
Material Deformation 22 22
Mechanical Jam 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
Failure to Run on Battery 9 9
No Device Output 9 9
Overheating of Device 9 9
Failure to Auto Stop 9 9
Material Integrity Problem 8 8
Material Twisted/Bent 8 8
Temperature Problem 8 8
Failure to Sense 8 8
Increased Pump Speed 7 7
Crack 7 7
Backflow 7 7
Physical Resistance/Sticking 7 7
No Pressure 7 7
Electrical Shorting 7 7
Electrical Power Problem 6 6
Contamination 6 6
Insufficient Cooling 6 6
Material Frayed 6 6
Fluid/Blood Leak 6 6
Decrease in Pressure 6 6
Device Inoperable 6 6
Unstable 5 5
Fitting Problem 5 5
Decreased Pump Speed 5 5
Low Readings 5 5
Corroded 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 Apparent Adverse Event 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 2093 2093
No Consequences Or Impact To Patient 1175 1175
No Patient Involvement 749 749
No Known Impact Or Consequence To Patient 265 265
Insufficient Information 187 187
Cardiac Arrest 37 37
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 I Dec-07-2023
4 Maquet Medical Systems USA II Nov-09-2023
5 Maquet Medical Systems USA II May-26-2023
6 Maquet Medical Systems USA II Apr-08-2022
7 Spectrum Medical Ltd. I Aug-23-2019
8 Terumo Cardiovascular Systems Corporation II Aug-26-2021
9 Terumo Cardiovascular Systems Corporation II Sep-12-2020
10 Terumo Cardiovascular Systems Corporation II Feb-07-2020
11 Terumo Cardiovascular Systems Corporation II Jun-11-2019
12 Terumo Cardiovascular Systems Corporation II May-15-2019
13 Terumo Cardiovascular Systems Corporation II Oct-18-2018
14 Terumo Cardiovascular Systems Corporation II Sep-25-2018
15 Terumo Cardiovascular Systems Corporation II Apr-20-2018
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