BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 20332043 · Received September 30, 2024

    Report

    Report Number
    9612164-2024-04426
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 21, 2024
    Report Date
    September 30, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    QHW
    PMA / PMN Number
    K201057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DURING USE OF A BIOMEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THERE WAS A CRACK IN THE CONNECTOR ON THE CANNULA. THE CRACK LEAKED WHEN THE DEVICE WAS CONNECTED TO THE EXTRA CORPOREAL MEMBRANCE OXYGENATION (ECMO) CIRCUIT. THE ECMO PROCEDURE HAD TO BE STOPPED FOR A PERIOD OF LESS THAN 2 MINUTES WHICH CAUSED A VERY SHORT DELAY TO CUT OFF THE AFFECTED CONNECTOR AND REPLACE IT WITH ANOTHER CONNECTOR FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE. THE ECMO TUBING HAD TO BE SEPARATED FROM THE CANNULA. THE CANNULA REMAINED IN SITU AND WAS RECONNECTED TO THE ECMO CIRCUIT. IT WAS AN EMERGENCY PROCEDURE. THERE WERE NO VISIBLE SIGNS OF DAMAGE TO ANY PACKAGING. THERE WAS LESS THAN 50MLS OF BLOOD LOSS. NO TRANSFUSION WAS REQUIRED AS A RESULT OF THE MINIMAL BLOOD LOSS. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041141 BIO-MEDICUS LIFE SUPPORT TM SINGLE LUMEN ECMO CANNULA QHW MEDTRONIC MEXICO LS96555-025 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown