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TPLC
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show TPLC since
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Device
heat-exchanger, cardiopulmonary bypass
Product Code
DTR
Regulation Number
870.4240
Device Class
2
Premarket Reviews
Manufacturer
Decision
GISH BIOMEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MAQUET CARDIOPULMONARY AG
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
2
QUARA S.R.L.
SUBSTANTIALLY EQUIVALENT
1
QUEST MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
66
66
2015
96
96
2016
60
60
2017
69
69
2018
75
75
2019
35
35
2020
33
33
2021
11
11
2022
23
23
2023
19
19
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
132
132
Device Displays Incorrect Message
113
113
Leak/Splash
86
86
Device Operates Differently Than Expected
38
38
Device Sensing Problem
17
17
Other (for use when an appropriate device code cannot be identified)
15
15
Loss of Power
14
14
No Apparent Adverse Event
12
12
Air Leak
12
12
Failure to Deliver
12
12
Failure to Prime
10
10
Device Contamination with Chemical or Other Material
10
10
Adverse Event Without Identified Device or Use Problem
10
10
Difficult to Open or Close
9
9
Defective Device
9
9
Nonstandard Device
7
7
Appropriate Term/Code Not Available
7
7
Solder Joint Fracture
7
7
Insufficient Information
6
6
Infusion or Flow Problem
6
6
Gas/Air Leak
6
6
Display or Visual Feedback Problem
5
5
Defective Component
5
5
Mechanical Problem
5
5
Air/Gas in Device
5
5
No Flow
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Device Emits Odor
4
4
Moisture Damage
4
4
Detachment Of Device Component
4
4
Noise, Audible
4
4
Connection Problem
3
3
Pressure Problem
3
3
Increase in Pressure
3
3
Inaccurate Delivery
3
3
Burst Container or Vessel
3
3
Unintended Movement
3
3
Material Puncture/Hole
3
3
Sticking
3
3
Excess Flow or Over-Infusion
3
3
Particulates
3
3
Loss of or Failure to Bond
3
3
Self-Activation or Keying
3
3
Device Inoperable
3
3
Component Missing
3
3
Use of Device Problem
3
3
Improper Flow or Infusion
3
3
Material Rupture
2
2
Positioning Problem
2
2
Application Program Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
192
192
No Known Impact Or Consequence To Patient
168
168
No Clinical Signs, Symptoms or Conditions
53
53
No Patient Involvement
23
23
Blood Loss
22
22
No Information
9
9
No Patient involvement
7
7
Insufficient Information
7
7
Bacterial Infection
7
7
Fever
4
4
Electrolyte Imbalance
3
3
Renal Failure
3
3
Hemorrhage/Bleeding
3
3
Unspecified Infection
2
2
Death
2
2
Not Applicable
2
2
Malaise
2
2
Cardiac Arrest
2
2
Overdose
2
2
Underdose
2
2
Endocarditis
2
2
Sweating
1
1
No Code Available
1
1
Fatigue
1
1
Irregular Pulse
1
1
Respiratory Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Maquet Cardiovascular Us Sales, Llc
II
Mar-10-2014
2
Maquet Medical Systems USA
II
May-26-2023
3
Quest Medical, Inc
III
Apr-08-2011
4
Quest Medical, Inc.
II
May-22-2020
5
Quest Medical, Inc.
II
Dec-02-2015
6
Terumo Cardiovascular Corporation
II
Sep-29-2010
7
Terumo Cardiovascular Systems Corp
II
Oct-31-2014
8
Terumo Cardiovascular Systems Corp
II
Aug-02-2010
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