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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suction control, intracardiac, cardiopulmonary bypass
Product CodeDWD
Regulation Number 870.4430
Device Class 2

MDR Year MDR Reports MDR Events
2014 7 7
2015 37 37
2016 6 6
2017 12 12
2018 8 8
2019 13 13
2020 2 2
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 43 43
Fluid/Blood Leak 24 24
No Apparent Adverse Event 10 10
Device Operates Differently Than Expected 8 8
Device Contamination with Body Fluid 6 6
Pressure Problem 3 3
Suction Problem 3 3
Delivered as Unsterile Product 2 2
Device Slipped 2 2
Hole In Material 2 2
Mechanical Problem 1 1
Air Leak 1 1
Loss of or Failure to Bond 1 1
Detachment Of Device Component 1 1
Contamination 1 1
Restricted Flow rate 1 1
Sticking 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Prime 1 1
Structural Problem 1 1
Device Displays Incorrect Message 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Microbial Contamination of Device 1 1
Difficult to Open or Close 1 1
Infusion or Flow Problem 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 37 37
No Known Impact Or Consequence To Patient 28 28
Blood Loss 12 12
No Information 4 4
Hemorrhage/Bleeding 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Patient Problem/Medical Problem 1 1
Complaint, Ill-Defined 1 1

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