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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
ABIOMED INC.
SUBSTANTIALLY EQUIVALENT
1
CHALICE MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
2
EUROSETS S.R.L.
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
4
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
SORIN GROUP ITALIA S.R.L
SUBSTANTIALLY EQUIVALENT
3
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
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
311
311
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
399
399
Fluid Leak
217
217
Break
202
202
Infusion or Flow Problem
143
143
Increase in Pressure
126
126
Pressure Problem
111
111
Packaging Problem
101
101
Use of Device Problem
79
79
Coagulation in Device or Device Ingredient
72
72
Crack
70
70
Detachment of Device or Device Component
57
57
Device Operates Differently Than Expected
52
52
Unable to Obtain Readings
52
52
Defective Component
47
47
Obstruction of Flow
47
47
Insufficient Flow or Under Infusion
37
37
Improper Flow or Infusion
36
36
Manufacturing, Packaging or Shipping Problem
36
36
Adverse Event Without Identified Device or Use Problem
34
34
Material Deformation
31
31
Gas Output Problem
29
29
Fracture
27
27
Device Damaged Prior to Use
27
27
Connection Problem
25
25
Failure to Deliver
24
24
Defective Device
24
24
No Flow
24
24
Material Separation
24
24
Disconnection
23
23
Medical Gas Supply Problem
23
23
Contamination
20
20
Component Missing
19
19
Device Operational Issue
19
19
Device Sensing Problem
19
19
Insufficient Information
18
18
Noise, Audible
17
17
Improper Chemical Reaction
17
17
Decrease in Pressure
17
17
Mechanical Problem
17
17
Device Difficult to Setup or Prepare
16
16
Filtration Problem
16
16
Contamination /Decontamination Problem
15
15
Complete Blockage
15
15
Loose or Intermittent Connection
14
14
Air/Gas in Device
14
14
Shipping Damage or Problem
13
13
Low Readings
13
13
Inaccurate Delivery
13
13
Gas Leak
12
12
Output Problem
11
11
Tear, Rip or Hole in Device Packaging
11
11
Restricted Flow rate
10
10
Detachment Of Device Component
10
10
Pumping Stopped
9
9
Particulates
9
9
Dent in Material
9
9
Scratched Material
9
9
Partial Blockage
8
8
Air Leak
8
8
Material Integrity Problem
7
7
Device Contamination with Chemical or Other Material
7
7
Blocked Connection
6
6
Temperature Problem
6
6
Gradient Increase
5
5
Insufficient Heating
5
5
Failure to Prime
5
5
Failure to Sense
5
5
Out-Of-Box Failure
5
5
Device Inoperable
4
4
Incorrect, Inadequate or Imprecise Resultor Readings
4
4
Material Discolored
4
4
Misassembled
4
4
Loss of or Failure to Bond
4
4
Clumping in Device or Device Ingredient
4
4
Device Contaminated During Manufacture or Shipping
4
4
Incorrect Device Or Component Shipped
4
4
Device Markings/Labelling Problem
4
4
Device Issue
4
4
Free or Unrestricted Flow
3
3
Therapeutic or Diagnostic Output Failure
3
3
Appropriate Term/Code Not Available
3
3
Material Split, Cut or Torn
3
3
No Device Output
3
3
Unexpected Therapeutic Results
3
3
Fitting Problem
3
3
Incomplete or Missing Packaging
3
3
Microbial Contamination of Device
2
2
Improper or Incorrect Procedure or Method
2
2
Melted
2
2
Circuit Failure
2
2
Incorrect Measurement
2
2
Labelling, Instructions for Use or Training Problem
2
2
Inaccurate Flow Rate
2
2
Material Fragmentation
2
2
Patient Device Interaction Problem
2
2
No Apparent Adverse Event
2
2
Pumping Problem
2
2
Output below Specifications
2
2
Improper Device Output
2
2
Device Dislodged or Dislocated
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
778
778
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
No Information
74
74
Death
59
60
Insufficient Information
38
38
Hemorrhage/Bleeding
33
33
Low Oxygen Saturation
33
33
Injury
27
27
Hypoxia
14
14
Low Blood Pressure/ Hypotension
12
12
Cardiac Arrest
11
11
Air Embolism
8
8
Hemolysis
8
8
Unspecified Infection
7
7
Abnormal Blood Gases
6
6
Sepsis
6
6
Thrombus
6
6
No Code Available
5
5
Infarction, Cerebral
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Thrombosis/Thrombus
4
4
Inflammation
3
3
Bradycardia
3
3
Hypothermia
3
3
Thrombocytopenia
3
3
Thromboembolism
3
3
Patient Problem/Medical Problem
3
3
Respiratory Failure
3
3
Aortic Dissection
2
2
Hematuria
2
2
Alteration In Body Temperature
2
2
Septic Shock
2
2
Heart Failure
2
2
Hypovolemia
2
2
Ischemia
2
2
Lupus
2
2
Neurological Deficit/Dysfunction
2
2
Anemia
2
2
Autoimmune Disorder
2
2
Lactate Dehydrogenase Increased
2
2
Bacterial Infection
1
2
Anoxia
1
1
Adult Respiratory Distress Syndrome
1
1
Anaphylactic Shock
1
1
Coagulation Disorder
1
1
Congestive Heart Failure
1
1
Cardiopulmonary Arrest
1
1
Stroke/CVA
1
1
Dyspnea
1
1
Edema
1
1
Embolism
1
1
Embolus
1
1
Cardiac Enzyme Elevation
1
1
Paralysis
1
1
Pulmonary Edema
1
1
Respiratory Distress
1
1
Seizures
1
1
Hemorrhage, Cerebral
1
1
Hypersensitivity/Allergic reaction
1
1
Hyperventilation
1
1
Anxiety
1
1
Brain Injury
1
1
Disability
1
1
Laceration(s) of Esophagus
1
2
Loss of consciousness
1
1
Swelling
1
1
Therapeutic Effects, Unexpected
1
1
Tissue Damage
1
1
Transient Ischemic Attack
1
1
Jaundice
1
1
Not Applicable
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
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
Medtronic Perfusion Systems
II
Jul-04-2020
8
Terumo Cardiovascular Systems Corporation
II
Dec-14-2020
9
Terumo Cardiovascular Systems Corporation
II
Jul-30-2019
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