BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 19791760 · Received July 22, 2024

    Report

    Report Number
    9612164-2024-03310
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Report Date
    July 19, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    QHW
    PMA / PMN Number
    K201057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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 THROUGH A POST MARKET SURVEILLANCE CLINICAL SURVEY, THAT DURING USE OF THIS BIO-MEDICUS LIFE SUPPORT CANNULA, THE TUBING WAS REMOVED FROM THE CANNULA WITH A TUBING CLAMP FOR VENTING PURPOSES. REMOVAL OF THE TUBING WITH THE TUBING CLAMP CAUSED A CRACK IN THE CANNULA CONNECTOR. THE CRACK/DAMAGE IN THE CANNULA WAS NOT DETECTED IMMEDIATELY AND A SMALL CLOT FORMED BETWEEN THE TUBING AND THE CONNECTOR A FEW DAYS LATER. THE CUSTOMER STATED THAT THE CANNULA WAS USED WITHOUT ANY ISSUES REPORTED, THE CANNULA WAS NOT REPLACED BY A NEW CANNULA SINCE THERE WAS NO ISSUE WITH THE CANNULA ITSELF. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165279 BIO-MEDICUS LIFE SUPPORT TM Single lumen ECMO cannula QHW MEDTRONIC MEXICO LS96218-019 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown