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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
2
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
676
676
2019
857
857
2020
627
627
2021
729
729
2022
717
717
2023
761
761
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output Problem
683
683
Pumping Stopped
249
249
Pumping Problem
221
221
Display or Visual Feedback Problem
216
216
Device Displays Incorrect Message
184
184
Device Alarm System
183
183
Mechanical Problem
183
183
Battery Problem
163
163
Failure to Calibrate
162
162
Difficult to Open or Close
155
155
Incorrect, Inadequate or Imprecise Result or Readings
141
141
No Display/Image
132
132
Calibration Problem
128
128
Electrical /Electronic Property Problem
104
104
Charging Problem
100
100
Pressure Problem
91
91
Appropriate Term/Code Not Available
83
83
Failure to Power Up
82
82
Break
78
78
Communication or Transmission Problem
78
78
Device Operates Differently Than Expected
70
70
Infusion or Flow Problem
70
70
Power Problem
69
69
Device Sensing Problem
64
64
Failure to Pump
64
64
No Flow
58
58
Inadequate User Interface
49
49
False Alarm
46
46
Connection Problem
44
44
Failure to Read Input Signal
38
38
Inaccurate Flow Rate
32
32
Unexpected Shutdown
31
31
Insufficient Information
29
29
Erratic or Intermittent Display
27
27
Unable to Obtain Readings
27
27
Adverse Event Without Identified Device or Use Problem
26
26
Noise, Audible
24
24
Decoupling
23
23
Use of Device Problem
22
22
Material Deformation
22
22
Mechanical Jam
22
22
Loss of or Failure to Bond
21
21
Out-Of-Box Failure
20
20
Failure to Charge
19
19
Defective Alarm
19
19
Loose or Intermittent Connection
19
19
Loss of Power
19
19
Incorrect Measurement
19
19
Improper Flow or Infusion
19
19
Application Program Freezes, Becomes Nonfunctional
19
19
Fracture
18
18
Protective Measures Problem
14
14
Intermittent Communication Failure
13
13
Detachment of Device or Device Component
13
13
Smoking
12
12
Gas Output Problem
12
12
Leak/Splash
12
12
Increase in Pressure
11
11
Circuit Failure
11
11
Thermal Decomposition of Device
11
11
Defective Component
11
11
Gas/Air Leak
11
11
Device Slipped
10
10
Failure To Adhere Or Bond
10
10
Degraded
10
10
Failure to Run on Battery
9
9
No Device Output
9
9
Overheating of Device
9
9
Failure to Auto Stop
9
9
Material Integrity Problem
8
8
Material Twisted/Bent
8
8
Temperature Problem
8
8
Failure to Sense
8
8
Increased Pump Speed
7
7
Crack
7
7
Backflow
7
7
Physical Resistance/Sticking
7
7
No Pressure
7
7
Electrical Shorting
7
7
Electrical Power Problem
6
6
Contamination
6
6
Insufficient Cooling
6
6
Material Frayed
6
6
Fluid/Blood Leak
6
6
Decrease in Pressure
6
6
Device Inoperable
6
6
Unstable
5
5
Fitting Problem
5
5
Decreased Pump Speed
5
5
Low Readings
5
5
Corroded
5
5
Display Difficult to Read
5
5
No Audible Alarm
5
5
Inappropriate or Unexpected Reset
5
5
Data Problem
5
5
Material Split, Cut or Torn
4
4
Therapeutic or Diagnostic Output Failure
4
4
No Apparent Adverse Event
4
4
No Visual Prompts/Feedback
4
4
Impedance Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2093
2093
No Consequences Or Impact To Patient
1175
1175
No Patient Involvement
749
749
No Known Impact Or Consequence To Patient
265
265
Insufficient Information
187
187
Cardiac Arrest
37
37
Death
35
35
No Information
16
16
Air Embolism
8
8
Low Blood Pressure/ Hypotension
7
7
Low Oxygen Saturation
7
7
Blood Loss
6
6
Hemorrhage/Bleeding
6
6
Brain Injury
4
4
Arrhythmia
4
4
Asystole
4
4
Bronchial Hemorrhage
4
4
Bradycardia
3
3
Not Applicable
3
3
Valvular Stenosis
2
2
Multiple Organ Failure
2
2
Injury
2
2
Ischemia
2
2
Myocarditis
2
2
Burn(s)
2
2
Bacterial Infection
2
2
Airway Obstruction
2
2
Intracranial Hemorrhage
2
2
Exsanguination
2
2
Hematoma
2
2
Respiratory Arrest
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hemolytic Anemia
1
1
Hypoxia
1
1
Cardiopulmonary Arrest
1
1
Congenital Defect/Deformity
1
1
Collapse
1
1
Low Cardiac Output
1
1
Nervous System Injury
1
1
Embolism/Embolus
1
1
No Code Available
1
1
Shock from Patient Lead(s)
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
I
Dec-07-2023
4
Maquet Medical Systems USA
II
Nov-09-2023
5
Maquet Medical Systems USA
II
May-26-2023
6
Maquet Medical Systems USA
II
Apr-08-2022
7
Spectrum Medical Ltd.
I
Aug-23-2019
8
Terumo Cardiovascular Systems Corporation
II
Aug-26-2021
9
Terumo Cardiovascular Systems Corporation
II
Sep-12-2020
10
Terumo Cardiovascular Systems Corporation
II
Feb-07-2020
11
Terumo Cardiovascular Systems Corporation
II
Jun-11-2019
12
Terumo Cardiovascular Systems Corporation
II
May-15-2019
13
Terumo Cardiovascular Systems Corporation
II
Oct-18-2018
14
Terumo Cardiovascular Systems Corporation
II
Sep-25-2018
15
Terumo Cardiovascular Systems Corporation
II
Apr-20-2018
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