BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 18525435 · Received January 17, 2024

    Report

    Report Number
    9612164-2024-00269
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    January 8, 2024
    Report Date
    April 9, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    QHW
    UDI-DI
    00763000615437
    PMA / PMN Number
    K201057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE CONNECTOR WAS CRACKED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. IT WAS ALSO REPORTED THAT THE CANNULA WAS NOT CRACKED BEFORE INSERTION, HOWEVER THE HEMOSTASIS CAP WAS MISSED BETWEEN THE CANNULA AND THE INTRODUCER DURING INSERTION. SO, THE INTRODUCER WAS USED FOR INSERTION WITHOUT THE HEMOSTASIS CAP. THE CUSTOMER REPORTED THAT THE CAUSE OF THIS WAS THAT THE HEMOSTASIS CAP IS COMPLETELY TRANSPARENT AND IS NOT ON THE CANNULA BUT ON THE PROTECTIVE PACKAGING AROUND THE INTRODUCER. IT WAS TAKEN AS A PROTECTIVE PACKAGING AND NOT AS A PROTECTION FOR THE CANNULA. THE HEMOSTASIS CAP WAS SUBSEQUENTLY DISCARDED BEFORE INSERTION OF THE CANNULA. THE CUSTOMER ALSO REPORTED THAT ACCORDING TO THEIR EXPERIENCE, THERE IS A DEFICIENCY IN THE PLASTIC (IT IS TOO FRAGILE) EVEN IF THE HEMOSTASIS CAP IS ON, AND ALSO THAT THE COLOR AND/OR PLACEMENT OF THE HEMOSTASIS CAP IN THE PACKAGING IS AN ISSUE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS USED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THERE WAS NO LEAK FROM THE CANNULA, OR FROM THE CONNECTION BETWEEN A CANNULA AND A CONNECTOR. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE CANNULA IS STILL IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717385 BIO-MEDICUS LIFE SUPPORT TM SINGLE LUMEN ECMO CANNULA QHW MEDTRONIC MEXICO LS96218-019 226180042 00763000615437

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male