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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
Inappropriate Waveform 1 1
Insufficient Information 1 1
Difficult to Remove 1 1
Microbial Contamination of Device 1 1

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

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