BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION HOLLOW FIBER OXYGENATOR

    MDR report key: 24647591 · Received March 20, 2026

    Report

    Report Number
    2184009-2026-00371
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 30, 2026
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K240666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B.5.MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT PRESSURE INCREASED INITIALLY. PRESSURE WAS MEASURED PRE AND POST. PATIENTS PRE OPERATIVE PLATELET COUNT WAS ELEVATED 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.

    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

    IT WAS REPORTED THAT DURING CARDIAC SURGERY AND CARDIOPULMONARY BYPASS (CPB) USING A FUSION OXYGENATOR, HIGH PRESSURE EXCURSION (HPE) OCCURRED AT THE BEGINNING OF CPB AT THE 20-MINUTE MARK, AND THE PRE-MEMBRANE PRESSURE WAS OVER 350 MMHG. ALBUMIN AND EPOPROSTONOL WERE ADMINISTERED AND THE HPE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134596 FUSION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS BB811 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown