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Perfusion Pack (UDI 00803622133312)Recalls & reported problems

Livanova USA, Inc.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00803622133312), received between Mar 7, 2018 and Mar 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

  • Fluid/Blood Leak1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 7, 2018Fluid/Blood Leak; Fluid/Blood Leak

    LIVANOVA USA RECEIVED A REPORT THAT A LEAK WAS IDENTIFIED AT THE MALE LUER ON THE OXYGENATOR PURGE LINE OF THE CUSTOMER PERFUSION TUBING SET. THE USER TIGHTENED THE CONNECTION OF THE LINE TO THE OXYGENATOR AND WENT ON BYPASS. DESPITE SEVERAL ATTEMPTS TO TIGHTEN THE LINE, THE LEAK WAS OBSERVED AGAIN DURING THE CASE AND THE OXYGENATOR WAS CHANGED OUT. THIS EVENT WAS INITIALLY REPORTED BY SORIN GROUP (B)(4) AGAINST THE INSPIRE OXYGENATOR (SEE 9680841-2017-00032). HOWEVER, DURING COMPLAINT EVALUATION, IT WAS DISCOVERED THAT THE ISSUE WAS RELATED TO THE MALE LUER SUPPLIED BY LIVANOVA USA. THE PATIENT RECEIVED 4 UNITS OF BLOOD. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7319847 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.