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Device
oxygenator, cardiopulmonary bypass
Product Code
DTZ
Regulation Number
870.4350
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT
SUBSTANTIALLY EQUIVALENT
1
ABIOMED INC.
SUBSTANTIALLY EQUIVALENT
2
CHALICE MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
3
EUROSETS S.R.L.
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC
SUBSTANTIALLY EQUIVALENT
1
1. K230640
Affinity Fusion™ Oxygenator System
MEDTRONIC INC
SUBSTANTIALLY EQUIVALENT
2
1. K230640
Affinity Fusion™ Oxygenator System
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
1. K230640
Affinity Fusion™ Oxygenator System
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
4
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
3
SORIN GROUP ITALIA S.R.L
SUBSTANTIALLY EQUIVALENT
3
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
3
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2017
388
388
2018
321
321
2019
489
489
2020
442
442
2021
595
595
2022
559
559
2023
739
739
2024
134
134
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
491
491
Leak/Splash
479
479
Break
267
267
Infusion or Flow Problem
188
188
Increase in Pressure
182
182
Pressure Problem
147
147
Material Separation
145
145
Use of Device Problem
122
122
Packaging Problem
118
118
Crack
116
116
Obstruction of Flow
86
86
Coagulation in Device or Device Ingredient
76
76
Material Deformation
64
64
Gas Output Problem
63
63
Defective Component
62
62
Detachment of Device or Device Component
58
58
Unable to Obtain Readings
57
57
Adverse Event Without Identified Device or Use Problem
53
53
Device Operates Differently Than Expected
52
52
Manufacturing, Packaging or Shipping Problem
44
44
Insufficient Information
42
42
Insufficient Flow or Under Infusion
41
41
Improper Flow or Infusion
38
38
Shipping Damage or Problem
37
37
Connection Problem
35
35
Contamination
33
33
Fracture
31
31
Disconnection
30
30
Air/Gas in Device
30
30
Device Sensing Problem
29
29
Device Damaged Prior to Use
29
29
No Flow
28
28
Decrease in Pressure
27
27
Material Puncture/Hole
25
25
Mechanical Problem
25
25
Unexpected Therapeutic Results
25
25
Medical Gas Supply Problem
25
25
Failure to Deliver
24
24
Defective Device
24
24
Gas/Air Leak
23
23
Improper Chemical Reaction
23
23
Noise, Audible
23
23
Component Missing
21
21
Complete Blockage
20
20
Particulates
19
19
Low Readings
19
19
Device Operational Issue
19
19
Loose or Intermittent Connection
18
18
Contamination /Decontamination Problem
17
17
Inaccurate Delivery
17
17
Filtration Problem
17
17
Output Problem
17
17
Device Difficult to Setup or Prepare
16
16
Partial Blockage
14
14
Device Contamination with Chemical or Other Material
13
13
Tear, Rip or Hole in Device Packaging
13
13
Scratched Material
12
12
Temperature Problem
12
12
Dent in Material
11
11
Restricted Flow rate
11
11
Pumping Stopped
11
11
Detachment Of Device Component
10
10
Gradient Increase
10
10
Blocked Connection
10
10
Material Integrity Problem
8
8
Air Leak
8
8
Failure to Sense
7
7
Fitting Problem
6
6
Failure to Prime
6
6
Loss of or Failure to Bond
6
6
High Readings
6
6
Device Markings/Labelling Problem
6
6
Out-Of-Box Failure
5
5
Appropriate Term/Code Not Available
5
5
Pumping Problem
5
5
Device Alarm System
5
5
Insufficient Heating
5
5
Material Discolored
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Material Split, Cut or Torn
5
5
Patient Device Interaction Problem
4
4
Misassembled During Installation
4
4
Device Inoperable
4
4
Misassembled
4
4
Clumping in Device or Device Ingredient
4
4
Decoupling
4
4
Unintended Movement
4
4
Material Twisted/Bent
4
4
Device Contaminated During Manufacture or Shipping
4
4
Incorrect Device Or Component Shipped
4
4
Microbial Contamination of Device
4
4
Device Issue
4
4
Battery Problem
4
4
Incomplete or Missing Packaging
3
3
Free or Unrestricted Flow
3
3
Therapeutic or Diagnostic Output Failure
3
3
Output below Specifications
3
3
Backflow
3
3
Delivered as Unsterile Product
3
3
No Device Output
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1756
1756
No Patient Involvement
551
551
No Consequences Or Impact To Patient
490
490
No Known Impact Or Consequence To Patient
338
338
Blood Loss
137
137
Hemorrhage/Bleeding
97
97
Insufficient Information
86
86
No Information
74
74
Death
59
60
Low Oxygen Saturation
48
48
Injury
27
27
Cardiac Arrest
24
24
Hypoxia
21
21
Low Blood Pressure/ Hypotension
16
16
Hemolysis
11
11
Air Embolism
11
11
Sepsis
10
10
Abnormal Blood Gases
7
7
Unspecified Infection
7
7
Stroke/CVA
6
6
Thrombus
6
6
Thrombosis/Thrombus
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
No Code Available
5
5
Bradycardia
5
5
Anemia
5
5
Coagulation Disorder
5
5
Infarction, Cerebral
4
4
Inflammation
3
3
Ischemia
3
3
Hypothermia
3
3
Respiratory Failure
3
3
Thromboembolism
3
3
Patient Problem/Medical Problem
3
3
Ischemia Stroke
3
3
Thrombocytopenia
3
3
Lactate Dehydrogenase Increased
2
2
Swelling/ Edema
2
2
Asystole
2
2
Hematuria
2
2
Alteration In Body Temperature
2
2
Aortic Dissection
2
2
Heart Failure
2
2
Hypovolemia
2
2
Pulmonary Edema
2
2
Septic Shock
2
2
Lupus
2
2
Neurological Deficit/Dysfunction
2
2
Exsanguination
2
2
Hematoma
2
2
Autoimmune Disorder
2
2
Bacterial Infection
1
2
Exposure to Body Fluids
1
1
Anoxia
1
1
Adult Respiratory Distress Syndrome
1
1
Anaphylactic Shock
1
1
Cardiopulmonary Arrest
1
1
Dyspnea
1
1
Edema
1
1
Embolism
1
1
Embolus
1
1
Cardiac Enzyme Elevation
1
1
Congestive Heart Failure
1
1
Hemorrhage, Cerebral
1
1
Hypersensitivity/Allergic reaction
1
1
Hyperventilation
1
1
Paralysis
1
1
Pneumonia
1
1
Pulmonary Dysfunction
1
1
Shock
1
1
Swelling
1
1
Therapeutic Effects, Unexpected
1
1
Tissue Damage
1
1
Transient Ischemic Attack
1
1
Jaundice
1
1
Renal Failure
1
1
Respiratory Distress
1
1
Seizures
1
1
Hypoventilation
1
1
Cardiogenic Shock
1
1
Anxiety
1
1
Brain Injury
1
1
Disability
1
1
Laceration(s) of Esophagus
1
2
Loss of consciousness
1
1
Iatrogenic Source
1
2
Low Cardiac Output
1
1
Diminished Pulse Pressure
1
1
Increased Respiratory Rate
1
1
Respiratory Acidosis
1
1
Multiple Organ Failure
1
1
Not Applicable
1
1
Cardiovascular Insufficiency
1
1
Cough
1
1
Respiratory Insufficiency
1
1
Muscle/Tendon Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abiomed, Inc.
I
Feb-03-2022
2
GETINGE US SALES LLC
II
Dec-12-2019
3
LivaNova USA
II
May-23-2018
4
Maquet Cardiovascular Us Sales, Llc
II
Dec-17-2020
5
Maquet Cardiovascular Us Sales, Llc
II
Sep-13-2019
6
Maquet Cardiovascular Us Sales, Llc
I
Nov-28-2018
7
Maquet Medical Systems USA
II
Feb-13-2024
8
Maquet Medical Systems USA
II
May-30-2023
9
Maquet Medical Systems USA
II
May-26-2023
10
Maquet Medical Systems USA
II
Feb-28-2023
11
Maquet Medical Systems USA
II
Sep-19-2022
12
Medtronic Perfusion Systems
II
Jan-27-2023
13
Medtronic Perfusion Systems
II
Jul-04-2020
14
Terumo Cardiovascular Systems Corporation
II
Apr-05-2023
15
Terumo Cardiovascular Systems Corporation
II
Dec-14-2020
16
Terumo Cardiovascular Systems Corporation
II
Jul-30-2019
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