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TPLC
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Device
tubing, pump, cardiopulmonary bypass
Product Code
DWE
Regulation Number
870.4390
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANGIODYNAMICS
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
VORTEX MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
129
129
2015
133
133
2016
151
151
2017
131
131
2018
134
134
2019
82
82
2020
45
45
2021
41
41
2022
123
123
2023
287
287
2024
74
74
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
419
419
Leak/Splash
146
146
Device Operates Differently Than Expected
103
103
Crack
49
49
Disconnection
46
46
Obstruction of Flow
45
45
Material Puncture/Hole
40
40
Material Separation
38
38
Material Deformation
34
34
Misassembled
27
27
Noise, Audible
27
27
Improper Flow or Infusion
24
24
Defective Component
23
23
Air/Gas in Device
23
23
Break
22
22
Air Leak
19
19
Loose or Intermittent Connection
19
19
Pressure Problem
19
19
Adverse Event Without Identified Device or Use Problem
18
18
Filtration Problem
17
17
Device Displays Incorrect Message
17
17
Infusion or Flow Problem
16
16
Kinked
16
16
Increase in Pressure
16
16
No Flow
16
16
Detachment Of Device Component
14
14
Tear, Rip or Hole in Device Packaging
14
14
Device Misassembled During Manufacturing /Shipping
13
13
Failure to Prime
13
13
Misassembled During Installation
13
13
Connection Problem
12
12
Improper or Incorrect Procedure or Method
11
11
Mechanical Problem
11
11
Occlusion Within Device
11
11
Packaging Problem
11
11
Insufficient Information
10
10
Insufficient Flow or Under Infusion
10
10
Component Missing
8
8
Gas/Air Leak
8
8
Pumping Problem
8
8
Restricted Flow rate
8
8
Material Discolored
8
8
Hole In Material
8
8
Complete Blockage
6
6
Output Problem
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Device Contamination with Chemical or Other Material
6
6
Detachment of Device or Device Component
6
6
Defective Device
6
6
Malfunction
5
5
Device Damaged Prior to Use
5
5
Device Inoperable
5
5
Use of Device Problem
5
5
Temperature Problem
5
5
Material Integrity Problem
5
5
Decoupling
5
5
Fracture
5
5
Material Fragmentation
5
5
Nonstandard Device
5
5
Difficult to Remove
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Material Split, Cut or Torn
5
5
Component Misassembled
4
4
No Apparent Adverse Event
4
4
Pumping Stopped
4
4
Incorrect Measurement
4
4
No Display/Image
4
4
Contamination
4
4
Coagulation in Device or Device Ingredient
4
4
Device Dislodged or Dislocated
4
4
Device Markings/Labelling Problem
4
4
Improper Device Output
4
4
Device Slipped
3
3
Device Contamination with Body Fluid
3
3
Blocked Connection
3
3
Partial Blockage
3
3
Display or Visual Feedback Problem
3
3
Misconnection
3
3
Decrease in Pressure
3
3
Appropriate Term/Code Not Available
3
3
Torn Material
3
3
Patient Device Interaction Problem
3
3
Physical Property Issue
2
2
Off-Label Use
2
2
Particulates
2
2
Unable to Obtain Readings
2
2
Moisture Damage
2
2
Delivered as Unsterile Product
2
2
No Device Output
2
2
Inaccurate Flow Rate
2
2
Component(s), broken
2
2
Gas Output Problem
2
2
Loss of or Failure to Bond
2
2
Bent
2
2
Malposition of Device
2
2
Labeling, missing
2
2
Incorrect Or Inadequate Test Results
2
2
Shipping Damage or Problem
2
2
Free or Unrestricted Flow
2
2
Chemical Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
468
468
No Known Impact Or Consequence To Patient
360
360
No Consequences Or Impact To Patient
200
200
No Patient Involvement
97
97
Hemorrhage/Bleeding
83
83
Death
48
48
No Information
24
24
Blood Loss
20
20
Low Oxygen Saturation
14
14
Hemolysis
9
9
No Code Available
7
7
Insufficient Information
6
6
Hypovolemia
6
6
Air Embolism
5
5
Bradycardia
5
5
Cardiac Arrest
5
5
Hypoxia
5
5
Unspecified Infection
5
5
Low Blood Pressure/ Hypotension
4
4
Thrombus
4
4
Injury
4
4
Ischemia
3
3
Myocardial Infarction
2
2
Stroke/CVA
2
2
Bacterial Infection
2
2
Pulmonary Embolism
2
2
Exsanguination
2
2
Complaint, Ill-Defined
2
2
Brain Injury
2
2
Thrombosis
2
2
No Patient involvement
2
2
Patient Problem/Medical Problem
1
1
Pericardial Effusion
1
1
Ischemia Stroke
1
1
Thrombosis/Thrombus
1
1
Heart Failure/Congestive Heart Failure
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Discomfort
1
1
Transient Ischemic Attack
1
1
Perforation of Vessels
1
1
Hypothermia
1
1
Toxicity
1
1
Collapse
1
1
Coma
1
1
Respiratory Acidosis
1
1
Respiratory Failure
1
1
Sudden Cardiac Death
1
1
Cardiac Perforation
1
1
Vascular System (Circulation), Impaired
1
1
Internal Organ Perforation
1
1
Paralysis
1
1
Pneumonia
1
1
Renal Failure
1
1
Surgical procedure, repeated
1
1
Sepsis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics Inc. (Navilyst Medical Inc.)
II
May-20-2016
2
Datascope Corporation
II
Oct-11-2018
3
Datascope Corporation
III
Jun-06-2018
4
Datascope Corporation
II
May-08-2018
5
Datascope Corporation
II
Mar-23-2017
6
Datascope Corporation
II
Jun-15-2016
7
LivaNova USA
III
Feb-21-2018
8
LivaNova USA Inc.
III
Feb-27-2020
9
Maquet
II
Dec-20-2017
10
Maquet Cardiovascular, LLC
III
Mar-16-2011
11
Maquet Inc.
II
Oct-06-2010
12
Maquet Inc.
II
Sep-12-2010
13
Medtronic Cardiovascular Revascularization & Surgical Therap
II
Jun-23-2009
14
Medtronic Inc. Cardiac Rhythm Disease Management
II
Feb-20-2014
15
Medtronic Inc. Cardiac Rhythm Disease Management
II
Aug-27-2013
16
Medtronic Inc. Cardiac Rhythm Disease Management
II
Jan-18-2012
17
Medtronic Perfusion Systems
II
Sep-04-2015
18
Sorin Group USA, Inc.
II
Jul-29-2017
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