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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
2
SPECTRUM MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
676
676
2019
857
857
2020
627
627
2021
729
729
2022
720
720
2023
125
125
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output Problem
618
618
Device Displays Incorrect Message
184
184
Pumping Problem
180
180
Pumping Stopped
167
167
Display or Visual Feedback Problem
163
163
Device Alarm System
162
162
Mechanical Problem
154
154
Battery Problem
152
152
Difficult to Open or Close
134
134
No Display/Image
125
125
Failure to Calibrate
117
117
Incorrect, Inadequate or Imprecise Result or Readings
112
112
Calibration Problem
106
106
Charging Problem
93
93
Appropriate Term/Code Not Available
83
83
Failure to Power Up
76
76
Electrical /Electronic Property Problem
76
76
Device Operates Differently Than Expected
70
70
Break
69
69
Failure to Pump
61
61
Communication or Transmission Problem
60
60
Pressure Problem
60
60
Device Sensing Problem
58
58
Infusion or Flow Problem
56
56
No Flow
55
55
Power Problem
54
54
False Alarm
44
44
Inadequate User Interface
42
42
Connection Problem
39
39
Inaccurate Flow Rate
30
30
Unexpected Shutdown
29
29
Erratic or Intermittent Display
27
27
Unable to Obtain Readings
24
24
Use of Device Problem
22
22
Loss of or Failure to Bond
21
21
Out-Of-Box Failure
20
20
Noise, Audible
20
20
Mechanical Jam
20
20
Adverse Event Without Identified Device or Use Problem
20
20
Application Program Freezes, Becomes Nonfunctional
19
19
Loss of Power
19
19
Incorrect Measurement
18
18
Failure to Charge
18
18
Improper Flow or Infusion
18
18
Material Deformation
18
18
Loose or Intermittent Connection
17
17
Fracture
17
17
Defective Alarm
16
16
Decoupling
16
16
Protective Measures Problem
14
14
Insufficient Information
12
12
Gas Output Problem
12
12
Detachment of Device or Device Component
12
12
Defective Component
11
11
Leak/Splash
11
11
Thermal Decomposition of Device
11
11
Gas/Air Leak
11
11
Circuit Failure
10
10
Failure To Adhere Or Bond
10
10
Degraded
10
10
Device Slipped
10
10
Smoking
10
10
Failure to Run on Battery
9
9
No Device Output
8
8
Overheating of Device
8
8
Failure to Sense
8
8
Failure to Read Input Signal
8
8
Material Twisted/Bent
8
8
Material Integrity Problem
7
7
Failure to Auto Stop
7
7
Temperature Problem
7
7
Physical Resistance/Sticking
7
7
Increased Pump Speed
7
7
Electrical Shorting
7
7
Increase in Pressure
7
7
Backflow
7
7
Contamination
6
6
Fluid/Blood Leak
6
6
Device Inoperable
6
6
Intermittent Communication Failure
6
6
Electrical Power Problem
6
6
Inappropriate or Unexpected Reset
5
5
Material Frayed
5
5
Decreased Pump Speed
5
5
No Audible Alarm
5
5
Computer Software Problem
4
4
Corroded
4
4
Positioning Failure
4
4
Display Difficult to Read
4
4
Misconnection
4
4
Unstable
4
4
Device Damaged Prior to Use
4
4
Defective Device
4
4
High Readings
4
4
Impedance Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Unintended Movement
3
3
No Apparent Adverse Event
3
3
No Pressure
3
3
Activation Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1537
1537
No Consequences Or Impact To Patient
1175
1175
No Patient Involvement
749
749
No Known Impact Or Consequence To Patient
265
265
Insufficient Information
119
119
Death
35
35
Cardiac Arrest
29
29
No Information
16
16
Air Embolism
7
7
Low Blood Pressure/ Hypotension
6
6
Blood Loss
6
6
Hemorrhage/Bleeding
4
4
Low Oxygen Saturation
4
4
Not Applicable
3
3
Respiratory Arrest
2
2
Injury
2
2
Airway Obstruction
2
2
Arrhythmia
2
2
Exsanguination
2
2
Hematoma
2
2
Cardiopulmonary Arrest
1
1
Congenital Defect/Deformity
1
1
Bradycardia
1
1
Collapse
1
1
Low Cardiac Output
1
1
Hypoxia
1
1
Brain Injury
1
1
Hemolytic Anemia
1
1
No Code Available
1
1
Shock from Patient Lead(s)
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
Apr-08-2022
4
Spectrum Medical Ltd.
I
Aug-23-2019
5
Terumo Cardiovascular Systems Corporation
II
Aug-26-2021
6
Terumo Cardiovascular Systems Corporation
II
Sep-12-2020
7
Terumo Cardiovascular Systems Corporation
II
Feb-07-2020
8
Terumo Cardiovascular Systems Corporation
II
Jun-11-2019
9
Terumo Cardiovascular Systems Corporation
II
May-15-2019
10
Terumo Cardiovascular Systems Corporation
II
Oct-18-2018
11
Terumo Cardiovascular Systems Corporation
II
Sep-25-2018
12
Terumo Cardiovascular Systems Corporation
II
Apr-20-2018
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