BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 16644573 · Received March 30, 2023

    Report

    Report Number
    9612164-2023-01376
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    February 22, 2023
    Report Date
    August 8, 2023
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    QHW
    UDI-DI
    00763000615420
    PMA / PMN Number
    K201057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS EVIDENCE OF BONE WAX IN THE LUER PORT. ADDITIONAL VISUAL INSPECTION SHOWS EVIDENCE OF A CRACK IN THE PORT. DURING THE CLEANING PROCESS THERE WAS A LEAK FROM THE LUER PORT. REASON FOR RETURN WAS CONFIRMED. NOTES: D2 PRODUCT CODE: AS INFORMATION ON WHETHER THE CANNULA WAS USED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OR CARDIOPULMONARY BYPASS (CPB) WAS UNKNOWN, THERE ARE TWO POSSIBLE PRODUCT CODES; QHW AND DWF. G4 PMA / 510(K) #: AS INFORMATION ON WHETHER THE CANNULA WAS USED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OR CARDIOPULMONARY BYPASS (CPB) WAS UNKNOWN, THERE ARE TWO POSSIBLE PMA/510(K) NUMBERS; K201057 AND K201100. 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

    CONCLUSION: AFTER INVESTIGATION AT MEDTRONIC, COMPLAINT WAS CONFIRMED FOR LEAKING FROM THE LUER PORT. IT IS UNKNOWN WHAT MAY HAVE CAUSED THIS OCCURRENCE, AS RETURNED PRODUCT ANALYSIS INDICATED THAT THERE WAS BONE WAX IN THE LUER PORT. THE BONE WAX PRESENT WOULD NOT HAVE BEEN APPLIED DURING MANUFACTURING AND MOST LIKELY WOULD HAVE BEEN APPLIED BY THE END USER. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS RETURNED PRODUCT ANALYSIS FOUND NO EVIDENCE OF MANUFACTURING ISSUES WITH THE RETURNED DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS INCIDENCE. MEDTRONIC WILL CONTINUE TO MONITOR FOR FUTURE OCCURRENCES AND TRENDS. 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 RECEIVED ADDITIONAL INFORMATION THAT BONE WAX WAS NOT USED BEFORE OR DURING THE LEAK. UPDATED CONCLUSION: AFTER INVESTIGATION AT MEDTRONIC, COMPLAINT IS CONFIRMED FOR CRACK IN THE LUER PORT RESULTING IN A LEAK. IT IS UNKNOWN WHAT MAY HAVE CAUSED THIS OCCURRENCE, AS RETURNED PRODUCT ANALYSIS INDICATED THAT THERE WAS BONE WAX IN THE LUER PORT. THE BONE WAX PRESENT WOULD NOT HAVE BEEN APPLIED DURING MANUFACTURING AND MOST LIKELY WOULD HAVE BEEN APPLIED BY THE END USER. THE CRACK IN THE LUER PORT COULD BE CAUSED BY THE OVERTIGHTENING OF THE LUER CAP. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ABNORMALITIES DURING MANUFACTURING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS INCIDENCE. MEDTRONIC WILL CONTINUE TO MONITOR FOR FUTURE OCCURRENCES AND TRENDS. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, IT WAS REPORTED THAT THE INSERTION OF THE CANNULA WAS EASY BUT THE LUER LOCK DID NOT LOOK 100% SAFE. IT WAS REPORTED THAT THERE WAS A POSSIBILITY OF SUCKING AIR INTO THE CIRCUIT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES. THE CUSTOMER STATED THAT AIR WAS OBSERVED IN THE CIRCUIT. IT WAS STATED THAT INFORMATION ON WHETHER THE CANNULA WAS USED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OR CARDIOPULMONARY BYPASS (CPB) WAS UNKNOWN. IT WAS STATED THAT THE CONNECTION WAS NOT LEAKING, IT WAS THE LUERLOCK ON THE CANNULAE THAT SUCKED AIR. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS PLACED IN THE V. J. RIGHT WITHOUT ANY PROBLEMS. THE LUER LOCK WAS NOT TIGHT (LEAKY) AND AIR WAS DRAWN INTO THE CANNULA. IT WAS REPORTED THAT POTENTIALLY, THIS COULD HAVE LEAD TO AIR EMBOLISM AND BLEEDING (AS A RESULT OF EXCHANGE). IT WAS REPORTED THAT THE LEAK WAS LIKE THE CAP THAT CLOSED THE LUER LOCK WAS NOT TIGHT. THE CAP DID NOT FIT. THE CANNULA WAS BEING USED FOR DRAINAGE. THE LEAK WAS AN AIR LEAK, THERE WAS NO PATIENT BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173555 BIO-MEDICUS LIFE SUPPORT TM SINGLE LUMEN ECMO CANNULA QHW MEDTRONIC MEXICO LS96218-017 224683434 00763000615420

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male