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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
MEDTRONIC
SUBSTANTIALLY EQUIVALENT
1
QUARA S.R.L.
SUBSTANTIALLY EQUIVALENT
1
QUEST MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
35
35
2020
33
33
2021
11
11
2022
23
23
2023
18
18
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
36
36
Device Displays Incorrect Message
19
19
Leak/Splash
8
8
Defective Device
6
6
Device Sensing Problem
6
6
Gas/Air Leak
5
5
Air/Gas in Device
4
4
Material Puncture/Hole
3
3
Defective Component
3
3
Appropriate Term/Code Not Available
3
3
No Apparent Adverse Event
3
3
Use of Device Problem
3
3
Loss of Power
2
2
Therapeutic or Diagnostic Output Failure
2
2
Protective Measures Problem
2
2
Inaccurate Delivery
2
2
Excess Flow or Over-Infusion
2
2
Infusion or Flow Problem
2
2
Material Separation
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Noise, Audible
1
1
No Flow
1
1
Electrical /Electronic Property Problem
1
1
Display or Visual Feedback Problem
1
1
Difficult to Open or Close
1
1
Connection Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Detachment of Device or Device Component
1
1
Device Emits Odor
1
1
Data Problem
1
1
Solder Joint Fracture
1
1
Mechanics Altered
1
1
Particulates
1
1
Improper Flow or Infusion
1
1
Obstruction of Flow
1
1
Backflow
1
1
No Pressure
1
1
Visual Prompts will not Clear
1
1
Failure to Deliver
1
1
Microbial Contamination of Device
1
1
Pumping Stopped
1
1
Contamination
1
1
Material Integrity Problem
1
1
Device Damaged Prior to Use
1
1
Device Alarm System
1
1
Output Problem
1
1
Pressure Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
55
55
No Clinical Signs, Symptoms or Conditions
53
53
Insufficient Information
7
7
No Patient Involvement
5
5
Electrolyte Imbalance
3
3
Overdose
2
2
Blood Loss
1
1
Cardiac Arrest
1
1
No Known Impact Or Consequence To Patient
1
1
Bacterial Infection
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Maquet Medical Systems USA
II
May-26-2023
2
Quest Medical, Inc.
II
May-22-2020
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