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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alfapump system
Definition The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.
Product CodeSDQ
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 0 1 2 0

MDR Year MDR Reports MDR Events
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 1 1
Insufficient Information 1 1

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