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TPLC
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Device
monitor, blood-gas, on-line, cardiopulmonary bypass
Regulation Description
Cardiopulmonary bypass on-line blood gas monitor.
Product Code
DRY
Regulation Number
870.4330
Device Class
2
Premarket Reviews
Manufacturer
Decision
LIVANOVA DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
1
SPECTRUM MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
35
35
2021
42
42
2022
37
37
2023
41
41
2024
72
72
2025
16
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
106
106
Leak/Splash
54
54
Failure to Sense
10
38
Pumping Stopped
9
9
Device Sensing Problem
7
7
False Negative Result
6
6
Thermal Decomposition of Device
5
5
Failure to Power Up
4
4
Insufficient Information
4
4
Electrical /Electronic Property Problem
4
4
Smoking
4
4
Unable to Obtain Readings
3
3
Incorrect Measurement
3
3
Incorrect Interpretation of Signal
2
2
Fail-Safe Problem
2
2
Electrical Shorting
1
1
Overheating of Device
1
1
Unexpected Shutdown
1
1
Complete Loss of Power
1
1
Fail-Safe Did Not Operate
1
1
Increased Pump Speed
1
1
Use of Incorrect Control/Treatment Settings
1
1
Inappropriate or Unexpected Reset
1
1
Low Readings
1
1
Use of Device Problem
1
1
Under-Sensing
1
1
Disconnection
1
1
Misconnection
1
1
Calibration Problem
1
1
Operating System Becomes Nonfunctional
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
High pH
1
1
Fluid/Blood Leak
1
1
Sparking
1
1
Activation Failure
1
1
Decrease in Pressure
1
1
Failure to Pump
1
1
False Positive Result
1
1
Decrease in Suction
1
1
Image Display Error/Artifact
1
1
Crack
1
1
Improper or Incorrect Procedure or Method
1
1
Failure to Interrogate
1
1
Display or Visual Feedback Problem
1
1
Computer Software Problem
1
1
Degraded
1
1
Electrical Power Problem
1
1
Failure to Recalibrate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
196
224
No Consequences Or Impact To Patient
28
28
Insufficient Information
13
13
No Patient Involvement
7
7
No Known Impact Or Consequence To Patient
3
3
Hemorrhage/Bleeding
2
2
Blood Loss
2
2
Air Embolism
2
2
Injury
1
1
Death
1
1
Ischemia
1
1
No Information
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Maquet Cardiovascular Us Sales, Llc
II
Nov-12-2020
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