BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 16805643 · Received April 25, 2023

    Report

    Report Number
    2184009-2023-00194
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    March 27, 2023
    Report Date
    June 1, 2023
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    QHW
    UDI-DI
    00763000615420
    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

    CONCLUSION: AFTER INVESTIGATION AT MEDTRONIC, THE COMPLAINT WAS CONFIRMED FOR A CRACKED CANNULA BODY CONNECTOR. IT IS UNKNOWN WHAT MAY HAVE CAUSED THIS OCCURRENCE, HOWEVER, BASED ON THE AVAILABLE INFORMATION THIS COMPLAINT COULD BE THE RESULT OF A USE-RELATED ISSUE. THIS DAMAGE TO THE CANNULA CONNECTOR CAN OCCUR WHEN THE INTRODUCER IS INSERTED INTO THE CANNULA BODY WITHOUT THE USE OF THE HEMOSTASIS CAP. THE INTRODUCER HANDLE CAN CAUSE STRETCHING, CRAZING OR CRACKING WHEN IT IS FORCED INTO THE CONNECTOR. THE ISSUE IS MORE LIKELY TO OCCUR WITH THE ARTERIAL CANNULAE MODELS WITH A CLEAR HEMOSTASIS CAP THAT IS ATTACHED TO THE INTRODUCER ON THE PROVIDED CLEAR PROTECTIVE SHEATH. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT COMPLETED AS THERE IS NO EVIDENCE TO SUGGEST MANUFACTURING ISSUES WITH THE COMPLAINT DEVICE. MANUFACTURING INVESTIGATION WAS COMPLETED FOR THIS FAILURE MODE. IN THIS INVESTIGATION THE MANUFACTURING PROCESS WAS REVIEWED, AND THE HANDLING OF THE AFFECTED PART IS MINIMUM, JUST PICK AND PLACE INTO THE PACKAGING, NO ADDITIONAL ASSEMBLY. PRODUCT EVENT NOTIFICATION AND AWARENESS WAS GIVEN TO THE PRODUCTION PERSONNEL ABOUT THE IMPLICATIONS AND CONSEQUENCES THAT REPOR TED DEFECT HAS ON THE FIELD. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS INCIDENCE. REVIEW OF THE COMPLAINT FILE INDICATES SUFFICIENT INFORMATION WAS PROVIDED FOR COMPLETION OF THIS INVESTIGATION. MEDTRONIC WILL CONTINUE TO MONITOR FOR FUTURE OCCURRENCES AND TRENDS PER TREND ANALYSIS PROCEDURE. 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 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS LIFE SUPPORT CANNULA, THE CUSTOMER REPORTED THAT UPON OPENING THE PACKAGE A CRACK WAS OBSERVED IN THE COUPLING PIECE, THERE WAS NO LEAK. THE DEVICE WAS USED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WERE NO SUTURES NEAR THE DAMAGED PART. JUST A SAFETY STRAP. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS USED FOR ECMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465659 BIO-MEDICUS LIFE SUPPORT TM CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO QHW PERFUSION SYSTEMS LS96218-017 224715948 00763000615420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown