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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 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 857 857
2020 627 627
2021 729 729
2022 717 717
2023 814 814
2024 210 210

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 686 686
Pumping Stopped 272 272
Pumping Problem 235 235
Display or Visual Feedback Problem 222 222
Mechanical Problem 185 185
Device Alarm System 171 171
Difficult to Open or Close 166 166
Incorrect, Inadequate or Imprecise Result or Readings 148 148
Failure to Calibrate 137 137
Calibration Problem 131 131
Electrical /Electronic Property Problem 114 114
Battery Problem 112 112
Pressure Problem 107 107
Charging Problem 87 87
Communication or Transmission Problem 84 84
Failure to Power Up 76 76
Break 75 75
No Display/Image 74 74
Infusion or Flow Problem 73 73
Power Problem 67 67
Appropriate Term/Code Not Available 67 67
Failure to Pump 64 64
Device Sensing Problem 59 59
Failure to Read Input Signal 56 56
No Flow 51 51
Inadequate User Interface 50 50
Device Displays Incorrect Message 43 43
False Alarm 43 43
Connection Problem 34 34
Unexpected Shutdown 32 32
Insufficient Information 30 30
Unable to Obtain Readings 30 30
Adverse Event Without Identified Device or Use Problem 26 26
Mechanical Jam 23 23
Material Deformation 22 22
Noise, Audible 22 22
Decoupling 22 22
Loss of or Failure to Bond 21 21
Erratic or Intermittent Display 20 20
Use of Device Problem 20 20
Defective Alarm 19 19
Application Program Freezes, Becomes Nonfunctional 19 19
Improper Flow or Infusion 18 18
Inaccurate Flow Rate 16 16
Detachment of Device or Device Component 15 15
Incorrect Measurement 14 14
Protective Measures Problem 13 13
Intermittent Communication Failure 12 12
Fracture 12 12
Failure to Charge 12 12
Circuit Failure 11 11
Loose or Intermittent Connection 11 11
Increase in Pressure 11 11
Insufficient Cooling 10 10
Degraded 10 10
Device Slipped 10 10
Failure to Sense 9 9
No Device Output 9 9
Temperature Problem 9 9
Gas/Air Leak 9 9
Physical Resistance/Sticking 8 8
Overheating of Device 8 8
Failure to Run on Battery 8 8
Loss of Power 8 8
Leak/Splash 8 8
Thermal Decomposition of Device 8 8
Failure to Auto Stop 8 8
Smoking 7 7
Crack 7 7
Gas Output Problem 7 7
Increased Pump Speed 7 7
Material Integrity Problem 7 7
No Pressure 7 7
No Apparent Adverse Event 7 7
Material Twisted/Bent 6 6
Decrease in Pressure 6 6
Fluid/Blood Leak 6 6
No Audible Alarm 6 6
Contamination 6 6
Defective Component 6 6
Electrical Shorting 6 6
Low Readings 6 6
Unstable 5 5
Fitting Problem 5 5
Decreased Pump Speed 5 5
Data Problem 5 5
Therapeutic or Diagnostic Output Failure 4 4
Human-Device Interface Problem 4 4
Material Split, Cut or Torn 4 4
No Visual Prompts/Feedback 4 4
Material Frayed 4 4
Misconnection 4 4
Backflow 4 4
Positioning Failure 4 4
Display Difficult to Read 4 4
Device Damaged Prior to Use 4 4
Microbial Contamination of Device 4 4
Failure to Deliver 4 4
Structural Problem 4 4
Electrical Power Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2336 2336
No Consequences Or Impact To Patient 844 844
No Patient Involvement 508 508
Insufficient Information 209 209
No Known Impact Or Consequence To Patient 183 183
Cardiac Arrest 37 37
Death 28 28
Air Embolism 9 9
Low Oxygen Saturation 8 8
Hemorrhage/Bleeding 6 6
Low Blood Pressure/ Hypotension 4 4
Arrhythmia 4 4
Exsanguination 4 4
Asystole 4 4
Bronchial Hemorrhage 4 4
Not Applicable 3 3
Blood Loss 3 3
Brain Injury 3 3
Bradycardia 3 3
Burn(s) 2 2
Intracranial Hemorrhage 2 2
Hematoma 2 2
Bacterial Infection 2 2
Airway Obstruction 2 2
Ischemia 2 2
Injury 2 2
Myocarditis 2 2
No Information 2 2
Valvular Stenosis 2 2
Respiratory Arrest 2 2
Multiple Organ Failure 2 2
Embolism/Embolus 1 1
Shock from Patient Lead(s) 1 1
No Code Available 1 1
Low Cardiac Output 1 1
Nervous System Injury 1 1
Hemolytic Anemia 1 1
Hypoxia 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 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
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