Perfusion Pack (UDI 00803622124853)Recalls & reported problems
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00803622124853), received between Dec 14, 2018 and Dec 14, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (3 reports).
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
- Material Discolored3
Patient problems
- No Patient Involvement3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2018Material Discolored; Material Discolored
LIVANOVA RECEIVED A REPORT THAT BLACK MARKS WERE IDENTIFIED INSIDE THE PUMP HEAD TUBING OF MULTIPLE CUSTOM PERFUSION TUBING SETS DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8166721 ↗MalfunctionDec 14, 2018Material Discolored; Material Discolored
LIVANOVA RECEIVED A REPORT THAT A BLACK MARK WAS IDENTIFIED INSIDE THE PUMP HEAD TUBING OF THE CUSTOM PERFUSION TUBING SET DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8166717 ↗MalfunctionDec 14, 2018Material Discolored; Material Discolored
LIVANOVA RECEIVED A REPORT THAT A BLACK MARK WAS IDENTIFIED INSIDE THE PUMP HEAD TUBING OF THE CUSTOM PERFUSION TUBING SET DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8166713 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.