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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
Regulation Description Cardiopulmonary bypass heart-lung machine console.
Product CodeDTQ
Regulation Number 870.4220
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTURY HLM, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 627 627
2021 729 729
2022 717 717
2023 827 827
2024 863 863
2025 57 61

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 611 611
Pumping Stopped 359 363
Pumping Problem 345 349
Display or Visual Feedback Problem 220 220
Difficult to Open or Close 199 199
Device Alarm System 180 180
Mechanical Problem 167 167
Calibration Problem 132 132
Pressure Problem 126 126
Incorrect, Inadequate or Imprecise Result or Readings 123 123
Failure to Calibrate 119 119
Communication or Transmission Problem 107 107
Electrical /Electronic Property Problem 96 96
Infusion or Flow Problem 90 90
Failure to Read Input Signal 82 82
Power Problem 72 72
Device Sensing Problem 69 69
Break 68 68
Battery Problem 67 67
No Display/Image 63 63
Charging Problem 61 61
Failure to Power Up 60 60
Failure to Pump 58 58
Inadequate User Interface 57 57
No Flow 41 41
False Alarm 37 37
Insufficient Information 31 31
Unable to Obtain Readings 29 29
Unexpected Shutdown 27 27
Connection Problem 27 27
Adverse Event Without Identified Device or Use Problem 26 26
Material Deformation 24 24
Defective Alarm 23 23
Decoupling 22 22
Loss of or Failure to Bond 22 22
Low Readings 22 22
Application Program Freezes, Becomes Nonfunctional 20 20
Mechanical Jam 20 20
Noise, Audible 19 19
Improper Flow or Infusion 19 19
Computer Software Problem 17 17
Detachment of Device or Device Component 17 17
Incorrect Measurement 15 15
Increase in Pressure 14 14
Crack 12 12
Circuit Failure 12 12
Use of Device Problem 12 12
Failure to Charge 11 11
Inaccurate Flow Rate 10 10
Intermittent Communication Failure 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3006 3010
No Consequences Or Impact To Patient 399 399
Insufficient Information 249 249
No Patient Involvement 204 204
No Known Impact Or Consequence To Patient 77 77
Cardiac Arrest 36 36
Death 11 11
Low Oxygen Saturation 10 10
Air Embolism 10 10
Arrhythmia 8 8
Hemorrhage/Bleeding 8 8
Brain Injury 4 4
Asystole 4 4
Bronchial Hemorrhage 4 4
Exsanguination 4 4
Bone Fracture(s) 4 4
Low Blood Pressure/ Hypotension 4 4
Myocarditis 2 2
Blood Loss 2 2
Nervous System Injury 2 2
Valvular Stenosis 2 2
Multiple Organ Failure 2 2
Cardiovascular Insufficiency 2 2
Respiratory Arrest 2 2
Airway Obstruction 2 2
Aneurysm 2 2
Bacterial Infection 2 2
Bradycardia 2 2
Burn(s) 2 2
Hematoma 2 2
Intracranial Hemorrhage 2 2
Hemothorax 2 2
Ischemia 2 2
Sepsis 2 2
Hemolytic Anemia 1 1
Low Cardiac Output 1 1
Shock from Patient Lead(s) 1 1
Embolism/Embolus 1 1
Hypoxia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LivaNova Deutschland GmbH II Nov-27-2024
2 LivaNova USA Inc. III Feb-10-2020
3 Maquet Medical Systems USA III Sep-30-2024
4 Maquet Medical Systems USA II May-16-2024
5 Maquet Medical Systems USA II Feb-08-2024
6 Maquet Medical Systems USA II Dec-21-2023
7 Maquet Medical Systems USA II Dec-14-2023
8 Maquet Medical Systems USA I Dec-07-2023
9 Maquet Medical Systems USA II Nov-09-2023
10 Maquet Medical Systems USA II May-26-2023
11 Maquet Medical Systems USA II Apr-08-2022
12 Spectrum Medical Ltd. II Oct-24-2024
13 Terumo Cardiovascular Systems Corporation II Aug-26-2021
14 Terumo Cardiovascular Systems Corporation II Sep-12-2020
15 Terumo Cardiovascular Systems Corporation II Feb-07-2020
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