BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 19030695 · Received April 3, 2024

    Report

    Report Number
    9612164-2024-01565
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    February 28, 2024
    Report Date
    May 1, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    QHW
    PMA / PMN Number
    K201057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    B.5. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER CLARIFIED THAT THEY WERE GIVEN A CANNULA THAT WAS SMALLER THAN WHAT THEY REQUESTED.THEREFORE, THE CUSTOMER HAS NO COMPLAINT AGAINST THE DEVICE. THE CUSTOMER STATED THAT THE NURSING STAFF GAVE THEM A CANNULA THAT WAS MUCH SMALLER IN FR SIZE THAN WHAT THEY REQUESTED. THIS WAS THE REASON AS TO WHY THE CUSTOMER INITIALLY COMPLAINED TO THEM ABOUT THE POOR FLOWS. H.6.UPDATE TO FDC CODE 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 CUSTOMER FELT AS THOUGH THE FLOWS WERE NOT AS GOOD THROUGH THIS DEVICE WHEN COMPARED TO THE CUSTOMERS USUAL CANNULA OF CHOICE, EVEN THOUGH THE FLOW RATES ARE MEANT TO BE COMPARABLE, IF NOT A LITTLE BETTER. THE DEVICE WAS USED 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
    1783154 BIO-MEDICUS LIFE SUPPORT TM CATHETER, PERCUTANEOUS QHW MEDTRONIC MEXICO LS96360-025 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown