Perfusion Pack (UDI 00803622152832)Recalls & reported problems
All models of Perfusion Pack (77)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00803622152832), received between Jul 18, 2024 and Jul 18, 2024 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2024
UPON PRIMING OF CARDIOPULMONARY BYPASS OF THE CIRCUIT, PERFUSIONIST NOTICES CRYSTALLOID DRIPPING FROM ARTERIAL TEMPERATURE PORT. THAT PORT IS NOT A DESIGNED EXIT POINT. PERFUSIONIST CHANGED OUT THE OXYGENATOR, REPRIMED. PERFORMED PRE-BYPASS CHECKLIST AND PROCEEDED WITH CASE.
Patient problems: Insufficient Information
MAUDE report 19770891 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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