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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventricular bypass (assist) device
Definition A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.
Product CodeOKR
Regulation Number 870.3545
Device Class 3

MDR Year MDR Reports MDR Events
2019 2 2
2020 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Pumping Problem 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Test Result 2 2
Multiple Organ Failure 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Cardiac Arrest 1 1
Death 1 1
Thrombus 1 1
Hematuria 1 1

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