BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION HOLLOW FIBER OXYGENATOR

    MDR report key: 24775192 · Received April 3, 2026

    Report

    Report Number
    2184009-2026-00436
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 20, 2026
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K240666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 PRIOR TO USE OF A FUSION HOLLOW FIBER OXYGENATOR, IT WAS REPORTED THAT THE DEVICE HAD A FIBER LEAK. THERE WAS NO LOSS OF PATIENT BLOOD, AND NO TRANSFUSION WAS REQUIRED. THE SAME LEK OCCURRED IN MULTIPLE PACKS. PLASMA BREAKTHROUGH DID NOT OCCUR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472266 FUSION HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS BB811

    Patients

    Seq Age Sex Outcome Treatment
    1