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TPLC
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Device
console, heart-lung machine, cardiopulmonary bypass
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
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
136
136
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output Problem
679
679
Pumping Stopped
260
260
Pumping Problem
227
227
Display or Visual Feedback Problem
217
217
Mechanical Problem
185
185
Device Alarm System
165
165
Difficult to Open or Close
162
162
Incorrect, Inadequate or Imprecise Result or Readings
146
146
Failure to Calibrate
136
136
Calibration Problem
131
131
Battery Problem
112
112
Electrical /Electronic Property Problem
110
110
Pressure Problem
103
103
Charging Problem
85
85
Communication or Transmission Problem
81
81
Failure to Power Up
76
76
Break
74
74
No Display/Image
71
71
Infusion or Flow Problem
70
70
Appropriate Term/Code Not Available
67
67
Power Problem
64
64
Failure to Pump
64
64
Device Sensing Problem
56
56
Failure to Read Input Signal
53
53
No Flow
51
51
Inadequate User Interface
49
49
Device Displays Incorrect Message
43
43
False Alarm
43
43
Connection Problem
32
32
Unexpected Shutdown
32
32
Insufficient Information
30
30
Unable to Obtain Readings
28
28
Adverse Event Without Identified Device or Use Problem
24
24
Mechanical Jam
23
23
Material Deformation
22
22
Decoupling
22
22
Loss of or Failure to Bond
21
21
Noise, Audible
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
17
17
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
Degraded
10
10
Device Slipped
10
10
Insufficient Cooling
9
9
No Device Output
9
9
Temperature Problem
9
9
Gas/Air Leak
9
9
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 Sense
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
Physical Resistance/Sticking
7
7
Material Twisted/Bent
6
6
No Apparent Adverse Event
6
6
Decrease in Pressure
6
6
Fluid/Blood Leak
6
6
Contamination
6
6
Defective Component
6
6
Electrical Shorting
6
6
Low Readings
6
6
Unstable
5
5
Fitting Problem
5
5
No Audible Alarm
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
2272
2272
No Consequences Or Impact To Patient
844
844
No Patient Involvement
508
508
Insufficient Information
202
202
No Known Impact Or Consequence To Patient
183
183
Cardiac Arrest
37
37
Death
28
28
Air Embolism
7
7
Low Oxygen Saturation
7
7
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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