BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 19565610 · Received June 19, 2024

    Report

    Report Number
    9612164-2024-02890
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 15, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    QHW
    PMA / PMN Number
    K201057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO H6: UPDATED THE FDC CODE (ANNEX D) 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

    THE DEVICE WAS REPLACED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS EVIDENCE OF DAMAGE/CRACK IN THE CONNECTOR. THE HEMOSTASIS CAP WAS NOT RETURNED. R EASON FOR RETURN WAS CONFIRMED. 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. 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 BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THAT DURING UNPACKING A BROKEN CONNECTOR WAS DETECTED AND THE CANNULA WAS SCRATCHED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689275 BIO-MEDICUS LIFE SUPPORT TM SINGLE LUMEN ECMO CANNULA QHW MEDTRONIC MEXICO LS96218-017 227062398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown