BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALFLOW CONSOLE

    MDR report key: 23355450 · Received October 22, 2025

    Report

    Report Number
    3011468686-2025-00090
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    January 31, 2025
    Report Date
    February 25, 2026
    Manufacturer
    MC3 INC.
    Product Code
    QNR
    UDI-DI
    00721902555756
    PMA / PMN Number
    K230364
    Removal / Correction Number
    3011468686-10/10/2025-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION::THE REPORTED ISSUE OF DELTA P ALARMING WAS NOT VERIFIED DURING SERVICE. SERVICE TECHNICIAN TESTED DEVICE FOR 30 MINUTES WITH NO FAULT. REPAIR ON THE VITALFLOW DEVICE WILL NOT BE PERFORMED. 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

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A VITALFLOW CONSOLE INSTRUMENT, IT WAS REPORTED THAT DURING AN ECMO CASE, THE DELTA P WAS ALARMING. WHEN THE NURSE PRESSED THE SCREEN TO ADJUST THE PARAMETERS THE SCREEN WENT BLANK AND REBOOTED. THE RPMS AND FLOW WERE NOT IMPACTED AND FLOW TO THE PATIENT WAS NOT IMPACTED. THE SCREEN REBOOTED AND CAME BACK TO THE NORMAL OPERATION SCREEN. CHECKED CONNECTIONS AND EVERYTHING LOOKED NORMAL, THE UNIT WAS PLUGGED INTO THE CART POWER STRIP ALONG WITH ONE OTHER INSTRUMENT. THE STRIP WAS PLUGGED TO THE WALL. THE HEATER COOLER WAS NOT PLUGGED INTO THE STRIP BUT DIRECTLY TO THE WALL. THE UNIT IS STILL BEING USED AND HAS NOT REPEATED THE ISSUE. CUSTOMER PULLED THE CODES FROM THE USB AND IT SHOWED CODE E70. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505243 VITALFLOW CONSOLE BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR MC3 INC. 58100 00721902555756

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male