Perfusion Pack (UDI 00803622133718)Recalls & reported problems
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00803622133718), received between Mar 7, 2018 and Mar 7, 2018 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LIVANOVA RECEIVED A REPORT THAT A PATIENT WAS CONCERNED REGARDING "UNEXPECTED BAD OUTCOMES" THAT MAY OR MAY NOT BE RELATED TO THE CUSTOMER PERFUSION TUBING SET. ACCORDING TO THE REPORT, AN INSPECTION OF THE DEVICE BY THE PERFUSION STAFF DID NOT IDENTIFY ANY VISIBLE ABNORMALITIES. THE REPORT INDICATED THAT A PATIENT HAD EXPIRED, THOUGH NO FURTHER DETAILS ABOUT THE EVENT HAVE BEEN PROVIDED.
Patient problems: Death
MAUDE report 7319846 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.