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TPLC
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show TPLC since
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Device
detector, bubble, cardiopulmonary bypass
Product Code
KRL
Regulation Number
870.4205
Device Class
2
Premarket Reviews
Manufacturer
Decision
SORIN GROUP DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
6
6
2016
18
18
2017
11
11
2018
2
2
2019
4
4
2022
20
20
2023
17
17
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Readings
22
22
Device Sensing Problem
14
14
False Alarm
12
12
Break
7
7
Over-Sensing
6
6
Device Operational Issue
5
5
Detachment Of Device Component
4
4
Pumping Stopped
3
3
Under-Sensing
3
3
Device Alarm System
2
2
Failure to Sense
2
2
Device Displays Incorrect Message
2
2
Deflation Problem
2
2
Unexpected Shutdown
2
2
Material Integrity Problem
2
2
Physical Property Issue
1
1
Appropriate Term/Code Not Available
1
1
Difficult to Open or Close
1
1
Disconnection
1
1
Fracture
1
1
Failure to Reset
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Sensing Intermittently
1
1
Deformation Due to Compressive Stress
1
1
Communication or Transmission Problem
1
1
Connection Problem
1
1
Device Operates Differently Than Expected
1
1
Other (for use when an appropriate device code cannot be identified)
1
1
Device Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
40
40
No Consequences Or Impact To Patient
25
25
No Patient Involvement
14
14
No Known Impact Or Consequence To Patient
2
2
No Information
1
1
Air Embolism
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Terumo Cardiovascular Systems Corporation
II
Oct-08-2010
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