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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 398 398

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 717 717
Pumping Stopped 300 300
Pumping Problem 255 255
Display or Visual Feedback Problem 232 232
Mechanical Problem 193 193
Device Alarm System 183 183
Difficult to Open or Close 179 179
Incorrect, Inadequate or Imprecise Result or Readings 148 148
Failure to Calibrate 139 139
Calibration Problem 134 134
Pressure Problem 121 121
Electrical /Electronic Property Problem 120 120
Battery Problem 112 112
Communication or Transmission Problem 94 94
Charging Problem 89 89
Infusion or Flow Problem 79 79
Break 77 77
Failure to Power Up 76 76
No Display/Image 74 74
Failure to Read Input Signal 74 74
Power Problem 69 69
Appropriate Term/Code Not Available 67 67
Failure to Pump 65 65
Device Sensing Problem 63 63
Inadequate User Interface 55 55
No Flow 51 51
False Alarm 45 45
Device Displays Incorrect Message 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 28 28
Mechanical Jam 24 24
Material Deformation 23 23
Noise, Audible 23 23
Decoupling 23 23
Loss of or Failure to Bond 22 22
Defective Alarm 20 20
Erratic or Intermittent Display 20 20
Use of Device Problem 20 20
Application Program Freezes, Becomes Nonfunctional 19 19
Improper Flow or Infusion 18 18
Detachment of Device or Device Component 16 16
Inaccurate Flow Rate 16 16
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
Crack 10 10
Device Slipped 10 10
Temperature Problem 10 10
Gas/Air Leak 9 9
Failure to Sense 9 9
No Device Output 9 9
Overheating of Device 9 9
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
No Apparent Adverse Event 8 8
Physical Resistance/Sticking 8 8
Material Integrity Problem 7 7
No Pressure 7 7
Electrical Shorting 7 7
Low Readings 7 7
Smoking 7 7
Gas Output Problem 7 7
Increased Pump Speed 7 7
Decrease in Pressure 6 6
Fluid/Blood Leak 6 6
No Audible Alarm 6 6
Contamination 6 6
Defective Component 6 6
Material Twisted/Bent 6 6
Data Problem 5 5
Material Split, Cut or Torn 5 5
Unstable 5 5
Fitting Problem 5 5
Material Frayed 5 5
Decreased Pump Speed 5 5
Misconnection 4 4
Corroded 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
No Visual Prompts/Feedback 4 4
Therapeutic or Diagnostic Output Failure 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2506 2506
No Consequences Or Impact To Patient 844 844
No Patient Involvement 508 508
Insufficient Information 224 224
No Known Impact Or Consequence To Patient 183 183
Cardiac Arrest 37 37
Death 28 28
Air Embolism 9 9
Arrhythmia 8 8
Low Oxygen Saturation 8 8
Hemorrhage/Bleeding 6 6
Brain Injury 4 4
Low Blood Pressure/ Hypotension 4 4
Exsanguination 4 4
Asystole 4 4
Bronchial Hemorrhage 4 4
Not Applicable 3 3
Blood Loss 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
Hypoxia 1 1
Hemolytic Anemia 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 May-16-2024
4 Maquet Medical Systems USA II Feb-08-2024
5 Maquet Medical Systems USA II Dec-21-2023
6 Maquet Medical Systems USA II Dec-14-2023
7 Maquet Medical Systems USA I Dec-07-2023
8 Maquet Medical Systems USA II Nov-09-2023
9 Maquet Medical Systems USA II May-26-2023
10 Maquet Medical Systems USA II Apr-08-2022
11 Spectrum Medical Ltd. I Aug-23-2019
12 Terumo Cardiovascular Systems Corporation II Aug-26-2021
13 Terumo Cardiovascular Systems Corporation II Sep-12-2020
14 Terumo Cardiovascular Systems Corporation II Feb-07-2020
15 Terumo Cardiovascular Systems Corporation II Jun-11-2019
16 Terumo Cardiovascular Systems Corporation II May-15-2019
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