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TPLC
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show TPLC since
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Device
monitor, blood-gas, on-line, cardiopulmonary bypass
Product Code
DRY
Regulation Number
870.4330
Device Class
2
Premarket Reviews
Manufacturer
Decision
LIVANOVA DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
1
MAQUET CARDIOPULMONARY AG
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
1
SORIN GROUP DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
1
SPECTRUM MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
5
SPECTRUM MEDICAL, LLP
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
2
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
156
156
2015
231
231
2016
240
240
2017
61
61
2018
165
165
2019
63
63
2020
35
35
2021
42
42
2022
37
37
2023
41
41
2024
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
332
332
Leak/Splash
295
295
Connection Problem
137
137
Incorrect Or Inadequate Test Results
88
88
Fluid/Blood Leak
38
38
Thermal Decomposition of Device
35
35
Device Operates Differently Than Expected
25
25
Nonstandard Device
23
23
Smoking
18
18
Incorrect Measurement
18
18
Device Displays Incorrect Message
18
18
Electrical /Electronic Property Problem
15
15
Failure to Power Up
12
12
High Readings
10
10
No Display/Image
6
6
Failure to Calibrate
5
5
Overheating of Device
5
5
Impedance Problem
5
5
Invalid Sensing
4
4
Unable to Obtain Readings
4
4
Calibration Problem
4
4
High Test Results
4
4
Battery Problem
4
4
Insufficient Information
4
4
Low Readings
3
3
Device Sensing Problem
3
3
Electrical Shorting
3
3
Out-Of-Box Failure
3
3
Pumping Stopped
3
3
Device Inoperable
3
3
Crack
3
3
Improper Device Output
3
3
Circuit Failure
3
3
No Device Output
3
3
Low Test Results
3
3
Corroded
3
3
Electrical Overstress
3
3
Electrical Power Problem
2
2
Charred
2
2
Noise, Audible
2
2
Failure to Run on Battery
2
2
Loose or Intermittent Connection
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Emits Odor
2
2
Display or Visual Feedback Problem
2
2
Failure to Sense
2
2
Gas/Air Leak
1
1
Data Problem
1
1
High pH
1
1
Inappropriate or Unexpected Reset
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
379
379
No Patient Involvement
314
314
No Known Impact Or Consequence To Patient
142
142
No Clinical Signs, Symptoms or Conditions
140
140
Blood Loss
87
87
No Information
27
27
Insufficient Information
12
12
Not Applicable
9
9
Air Embolism
2
2
Death
2
2
Dysphasia
1
1
Ischemia
1
1
Injury
1
1
Full thickness (Third Degree) Burn
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Maquet Cardiovascular Us Sales, Llc
II
Nov-12-2020
2
Terumo Cardiovascular Systems Corporation
II
Aug-11-2018
3
Terumo Cardiovascular Systems Corporation
III
Oct-03-2016
4
Terumo Cardiovascular Systems Corporation
II
Mar-25-2016
5
Terumo Cardiovascular Systems Corporation
II
Sep-09-2015
6
Terumo Cardiovascular Systems Corporation
II
May-19-2014
7
Terumo Cardiovascular Systems Corporation
II
Jul-13-2013
8
Terumo Cardiovascular Systems Corporation
II
Feb-12-2013
9
Terumo Cardiovascular Systems Corporation
II
Apr-06-2012
10
Terumo Cardiovascular Systems Corporation
II
Jan-11-2012
11
Terumo Cardiovascular Systems Corporation
II
Jan-11-2012
12
Terumo Cardiovascular Systems Corporation
II
Oct-31-2011
13
Terumo Cardiovascular Systems Corporation
II
Jun-28-2011
14
Terumo Cardiovascular Systems Corporation
II
Jun-22-2011
15
Terumo Cardiovascular Systems Corporation
II
May-12-2011
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