BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION HOLLOW FIBER OXYGENATOR

    MDR report key: 23603410 · Received November 20, 2025

    Report

    Report Number
    2184009-2025-01508
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 20, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K240666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT THERE WAS A HIGH PRESSURE EXCURSION (HPE) EVENT WHILE USING THE DEVICE DURING CARDIOPULMONARY BYPASS SURGERY. THE CUSTOMER WAS UNABLE TO ACHIEVE FULL FLOW DUE TO THEIR PRE-MEMBRANE PRESSURE EXCEEDING 500MMHG. THEY HAD TO CALL FOR 100ML OF 25% ALBUMIN TO HELP WITH THE HPE EVENT. THEY DECIDED NOT TOO COOL THE PATIENT AND KEEP THEM WARM. THEY HAD TO INCREASE THE FIO2 TO 100% BECAUSE THE GAS EXCHANGE WAS COMPROMISED DUE TO THE HPE EVENT. THE USE OF THE DEVICE WAS UNSPECIFIED. IT WAS UNKNOWN IF THERE WAS ANY ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468195 FUSION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS BB811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown