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Device
console, heart-lung machine, cardiopulmonary bypass
Regulation Description
Cardiopulmonary bypass heart-lung machine console.
Product Code
DTQ
Regulation Number
870.4220
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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