Perfusion Pack (UDI 00803622147050)Recalls & reported problems
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622147050), received between Sep 1, 2022 and Sep 26, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (2 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.
Reports received per month
Most reported problems
Device problems
- Disconnection2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hypovolemia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2024Disconnection; Disconnection
LIVANOVA USA INC. RECEIVED A REPORT RELATED TO THE DISCONNECTION OF THE Y CONNECTOR PLACED IN THE OUTLET LINE OF THE ARTERIAL FILTER. THE ISSUE OCCURRED DURING PRIMING WITH FLOW AT 6 LPM. THE LINE WAS RE-CONNECTED BY THE PERFUSIONIST AND THE CIRCUIT USED FOR THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20307755 ↗InjurySep 1, 2022Disconnection; Disconnection
LIVANOVA HAS RECEIVED A REPORT THAT, DURING A BYPASS PROCEDURE, THE ARTERIAL LINE TUBING DISCONNECTED FROM THE OUTLET OF THE RESERVOIR. THE PERFUSIONIST RECONNECTED AND TIE BANDED IT. THIS IS A CONNECTION THE PERFUSIONIST MAKES. APPROXIMATELY 2 LITERS OF PATIENT BLOOD WAS LOST. THERE IS NO REPORT OF ANY PATIENT INJURY
Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions
MAUDE report 15336024 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.