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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device right ventricular bypass (assist) device
Definition To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
Product CodeOJE
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2021 2 2
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Difficult to Remove 1 1
Microbial Contamination of Device 1 1
Inappropriate Waveform 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abscess 1 1
Hematoma 1 1
Perforation 1 1
Thrombosis/Thrombus 1 1
Retroperitoneal Hemorrhage 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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