Perfusion Pack (UDI 00803622142550)Recalls & reported problems
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00803622142550), received between Oct 26, 2022 and Dec 3, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Air/Gas in Device” (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
- Air/Gas in Device2
- Fluid/Blood Leak1
Patient problems
- Insufficient Information2
- Hypovolemia1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2024Air/Gas in Device; Air/Gas in Device
LIVANOVA USA INC. RECEIVED A REPORT RELATED TO AN AIR INGRESS INTO A PERFUSION TUBING SYSTEM (PTS) PACK. IN DETAIL, CARDIOPLEGIA LINE WAS PRIMED AND FLUSHED WITH NO LEAKS NOTED WHEN OVER-PRESSURIZED WHILE IN PRIMING MODE. ONCE CROSS CLAMP WAS ON, WHILE DELIVERING THE CARDIOPLEGIA SOLUTION TO THE PATIENT, THE DELIVERY SYSTEM AND LINE FILLED WITH AIR. DELIVERY WAS THEN STOPPED AND ATTEMPTED TO FLUSH AIR TO THE FIELD. HOWEVER, MORE AIR CAME INTO DELIVERY SYSTEM. THEREFORE, CROSS CLAMP WAS REMOVED. PATIENT WAS DEFIBRILLATED AND CARDIOPLEGIA SYSTEM WAS EXCHANGED FOR NEW ONE. NEW CARDIOPLEGIA CIRCUIT WAS PRIMED AND FLUSHED TO THE FIELD. CROSS CLAMP WAS PLACED AND CARDIOPLEGIA WAS DELIVERED WITH NO AIR ISSUES.
Patient problems: Insufficient Information
MAUDE report 20830134 ↗InjuryDec 3, 2024Air/Gas in Device; Air/Gas in Device
InjuryOct 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
SORIN GROUP ITALIA RECEIVED A REPORT THAT, ON (B)(6) 2022, ABOUT 30 MINUTES SINCE ON PUMP, THE PURGE LINE BEGAN LEAKING. THE PERFUSIONIST OCCLUDED THE LINE AND STOP BLOOD LOSS IN ABOUT 20-30 SECS. HOWEVER, AN ESTIMATED 500ML WAS LOST. UPON INSPECTION, THE ONE-WAY VALVE WAS SPLIT IN HALF. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT AND THE PATIENT COME OFF BYPASS SUCCESSFULLY. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: Hypovolemia
MAUDE report 15672370 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.