BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALFLOW CONSOLE

    MDR report key: 23451887 · Received November 3, 2025

    Report

    Report Number
    3011468686-2025-00108
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    September 19, 2025
    Report Date
    March 2, 2026
    Manufacturer
    MC3 INC.
    Product Code
    QNR
    PMA / PMN Number
    K250199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT MEDTRONIC SERVICE AND REPAIR WAS UNABLE TO CONFIRM CUSTOMER'S COMPLAIN ON ANALYSIS. REPAIR 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

    FDR. FDC CODES UPDATED 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

    D9: THE DEVICE HAS BEEN RECEIVED FOR EVALUATION BUT EVALUATION HAS NOT BEEN PERFORMED YET. 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

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION OF THE 1 RETURNED DEVICE SHOWS NO OUTWARD SIGNS OF ANY DAMAGE. DEVICE WILL BE TESTED BY THE SUPPLIER SERVICE TEAM MINNETRONIX. REASON FOR THE RETURN WAS UNDETERMINED. ADDITIONAL INFO A2: UPDATED PATIENTS AGE AND DATE OF BIRTH INFORMATION UPDATED. ADDITIONAL INFO A3 (A): PATIENTS SEX INFORMATION UPDATED. ADDITIONAL INFO A4: PATIENTS WEIGHT INFORMATION UPDATED. 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 ERROR CODE 10 WAS OBSERVED. THE PUMP HEAD MADE A WHINING NOISE AND SHUT OFF. THE FLOW AND RPM DROPPED TO ZERO. THE INSTRUMENT WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A VALVE WAS BROKEN. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FLOW TO THE PATIENT DECREASED SIGNIFICANTLY. THE CUSTOMER UTILIZED THE HAND CRANK TO ENSURE THERE WAS CONTINUOUS FLOW TO THE PATIENT. THERE WAS NO IMPACT TO THE PATIENT ASSOCIATED WITH THIS EVENT. THE PATIENT WAS EVENTUALLY SWITCHED OVER TO A DIFFERENT EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020255 VITALFLOW CONSOLE BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR MC3 INC. 58100

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention