BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 19481456 · Received June 6, 2024

    Report

    Report Number
    9612164-2024-02668
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    June 3, 2024
    Report Date
    November 21, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    QHW
    PMA / PMN Number
    K240534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS EVIDENCE OF DAMAGE/CRACK IN THE CONNECTOR. THE HEMOSTASIS CAP WAS NOT RETURNED. THE TIP OF THE INTRODUCER WAS OBSERVED UNDER MAGNIFICATION AND THERE WAS NO EVIDENCE OF ANY DAMAGE. REASON FOR RETURN WAS CONFIRMED FOR A CRACKED CONNECTOR. CORRECTION H6.1 DEVICE CODES (FDD/ANNEX A): THIS FIELD WAS 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

    B.5.MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP WAS NOT RECOVERED. THE TIP DID NOT FALL INTO THE PATIENT. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE SAME INSERTION SITE WAS USED FOR THE REPLACED CANNULA. 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 BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE TIP OF THE CANNULA WAS DETACHED. THE DEVICE WAS REPLACED 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
    1100474 BIO-MEDICUS LIFE SUPPORT TM SINGLE LUMEN ECMO CANNULA QHW MEDTRONIC MEXICO LS96555-021 227145851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown