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TPLC
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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
1. K191246
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405
...
2. K201642
Paragon Adult Maxi PMP Oxygenator with Tubing Pack
3. K231414
CMO8 Adult PMP Oxygenator with Tubing Pack (Model:
...
EUROSETS S.R.L.
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
2
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
3
SORIN GROUP ITALIA S.R.L
SUBSTANTIALLY EQUIVALENT
2
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
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
431
431
Leak/Splash
343
343
Break
197
197
Infusion or Flow Problem
161
161
Increase in Pressure
151
151
Material Separation
145
145
Packaging Problem
114
114
Pressure Problem
107
107
Use of Device Problem
97
97
Obstruction of Flow
81
81
Crack
77
77
Coagulation in Device or Device Ingredient
65
65
Gas Output Problem
58
58
Unable to Obtain Readings
57
57
Detachment of Device or Device Component
56
56
Defective Component
55
55
Material Deformation
52
52
Adverse Event Without Identified Device or Use Problem
42
42
Manufacturing, Packaging or Shipping Problem
40
40
Insufficient Information
38
38
Shipping Damage or Problem
34
34
Insufficient Flow or Under Infusion
33
33
Contamination
33
33
Air/Gas in Device
30
30
Improper Flow or Infusion
29
29
Device Sensing Problem
29
29
No Flow
26
26
Unexpected Therapeutic Results
25
25
Material Puncture/Hole
25
25
Mechanical Problem
24
24
Failure to Deliver
23
23
Improper Chemical Reaction
23
23
Defective Device
22
22
Noise, Audible
22
22
Decrease in Pressure
22
22
Disconnection
21
21
Gas/Air Leak
19
19
Connection Problem
18
18
Contamination /Decontamination Problem
17
17
Fracture
17
17
Inaccurate Delivery
17
17
Device Damaged Prior to Use
16
16
Device Difficult to Setup or Prepare
16
16
Loose or Intermittent Connection
16
16
Particulates
16
16
Output Problem
16
16
Medical Gas Supply Problem
15
15
Scratched Material
12
12
Partial Blockage
12
12
Component Missing
12
12
Pumping Stopped
11
11
Restricted Flow rate
11
11
Dent in Material
11
11
Gradient Increase
10
10
Tear, Rip or Hole in Device Packaging
9
9
Low Readings
9
9
Blocked Connection
9
9
Device Contamination with Chemical or Other Material
9
9
Temperature Problem
9
9
Complete Blockage
8
8
Failure to Sense
7
7
Filtration Problem
7
7
Material Integrity Problem
7
7
Device Markings/Labelling Problem
6
6
High Readings
6
6
Loss of or Failure to Bond
6
6
Device Alarm System
5
5
Fitting Problem
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Appropriate Term/Code Not Available
5
5
Material Split, Cut or Torn
5
5
Misassembled During Installation
4
4
Patient Device Interaction Problem
4
4
Unintended Movement
4
4
Pumping Problem
4
4
Battery Problem
4
4
Material Twisted/Bent
4
4
Device Contaminated During Manufacture or Shipping
4
4
Failure to Prime
4
4
Microbial Contamination of Device
4
4
Clumping in Device or Device Ingredient
4
4
Material Discolored
4
4
Delivered as Unsterile Product
3
3
Backflow
3
3
Decoupling
3
3
Incomplete or Missing Packaging
3
3
Material Rupture
3
3
Therapeutic or Diagnostic Output Failure
3
3
Suction Failure
3
3
Priming Problem
2
2
Missing Information
2
2
Output below Specifications
2
2
Power Problem
2
2
Misassembly by Users
2
2
No Apparent Adverse Event
2
2
Device Dislodged or Dislocated
2
2
Free or Unrestricted Flow
2
2
Deformation Due to Compressive Stress
2
2
Device Ingredient or Reagent Problem
2
2
No Device Output
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1756
1756
No Patient Involvement
321
321
No Consequences Or Impact To Patient
320
320
No Known Impact Or Consequence To Patient
174
174
Hemorrhage/Bleeding
89
89
Insufficient Information
86
86
Blood Loss
60
60
No Information
50
50
Death
38
38
Low Oxygen Saturation
37
37
Cardiac Arrest
23
23
Hypoxia
21
21
Injury
16
16
Low Blood Pressure/ Hypotension
14
14
Hemolysis
11
11
Air Embolism
9
9
Sepsis
9
9
Unspecified Infection
6
6
Thrombosis/Thrombus
6
6
Stroke/CVA
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Abnormal Blood Gases
5
5
Anemia
5
5
Bradycardia
5
5
Coagulation Disorder
4
4
Hypothermia
3
3
Ischemia
3
3
Ischemia Stroke
3
3
Thrombocytopenia
3
3
Thromboembolism
3
3
Respiratory Failure
3
3
Hypovolemia
2
2
Inflammation
2
2
Thrombus
2
2
Septic Shock
2
2
Aortic Dissection
2
2
Lactate Dehydrogenase Increased
2
2
Swelling/ Edema
2
2
Asystole
2
2
Lupus
2
2
Neurological Deficit/Dysfunction
2
2
Exsanguination
2
2
Hematoma
2
2
Autoimmune Disorder
2
2
Infarction, Cerebral
2
2
Cardiopulmonary Arrest
1
1
Dyspnea
1
1
Edema
1
1
Embolism
1
1
Exposure to Body Fluids
1
1
Anoxia
1
1
Adult Respiratory Distress Syndrome
1
1
Anaphylactic Shock
1
1
Hypoventilation
1
1
Hypersensitivity/Allergic reaction
1
1
Pneumonia
1
1
Pulmonary Dysfunction
1
1
Pulmonary Edema
1
1
Renal Failure
1
1
Respiratory Distress
1
1
Seizures
1
1
Cardiovascular Insufficiency
1
1
Cough
1
1
Respiratory Insufficiency
1
1
Muscle/Tendon Damage
1
1
Low Cardiac Output
1
1
Hematuria
1
1
Diminished Pulse Pressure
1
1
Multiple Organ Failure
1
1
Shock
1
1
Swelling
1
1
Therapeutic Effects, Unexpected
1
1
Transient Ischemic Attack
1
1
Jaundice
1
1
Cardiogenic Shock
1
1
Anxiety
1
1
Heart Failure
1
1
Brain Injury
1
1
Increased Respiratory Rate
1
1
Loss of consciousness
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
Maquet Cardiovascular Us Sales, Llc
II
Dec-17-2020
4
Maquet Cardiovascular Us Sales, Llc
II
Sep-13-2019
5
Maquet Medical Systems USA
II
Feb-13-2024
6
Maquet Medical Systems USA
II
May-30-2023
7
Maquet Medical Systems USA
II
May-26-2023
8
Maquet Medical Systems USA
II
Feb-28-2023
9
Maquet Medical Systems USA
II
Sep-19-2022
10
Medtronic Perfusion Systems
II
Jan-27-2023
11
Medtronic Perfusion Systems
II
Jul-04-2020
12
Terumo Cardiovascular Systems Corporation
II
Apr-05-2023
13
Terumo Cardiovascular Systems Corporation
II
Dec-14-2020
14
Terumo Cardiovascular Systems Corporation
II
Jul-30-2019
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