BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS LIFE SUPPORT TM

    MDR report key: 16895119 · Received May 9, 2023

    Report

    Report Number
    2184009-2023-00240
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 6, 2023
    Report Date
    July 17, 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 THE COMPLAINT IS CONFIRMED FOR A CRACKED CANNULA BODY CONNECTOR BASED ON THE PHOTO PROVIDED, HOWEVER, NO PRODUCT HAS BEEN RETURNED. 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 FOUND NO ABNORMALITIES DURING MANUFACTURING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. A MANUFACTURING INVESTIGATION WAS COMPLETED FOR THIS FAI LURE MODE IN THIS INVESTIGATION THE MANUFACTURING PROCESS WAS REVIEWED, AND THE HANDLE OF THE AFFECTED PART IS MINIMUM, JUST PICK AND PLACE INTO THE PACKAGING, NO ADDITIONAL ASSEMBLY. REVIEW OF IN-PROCESS PICTURES SHOWED THAT THE PIECES PRODUCED ARE IN GOOD CONDIT ION. PRODUCT EVENT NOTIFICATION AND AWARENESS WAS GIVEN TO THE PRODUCTION PERSONNEL ABOUT THE IMPLICATIONS AND CONSEQUENCES THAT REPORTED DEFECT HAS ON THE FIELD. COMPLAINTS RECEIVED FOR SIMILAR MODEL NUMBERS WERE REVIEWED AND SHOWED NO TRENDS WARRANTING ESCALATION RELATED TO THIS OCCURRENCE. THERE WERE NO ADVERSE PATIENT EFFECTS BECAUSE OF THIS INCIDENCE. MEDTRONIC WILL CONTINUE TO MONITOR FOR FUTURE OCCURRENCES AND TRENDS. CORRECTION E (STREET 1) AND E (REGION): THESE FIELDS HAVE BEEN UPDATED. 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

    CONTINUED FROM D4 LOT #: IT WAS REPORTED THAT THE LOT NUMBER IS PROBABLY 224715948, THE CUSTOMER WAS NOT SURE. 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. 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, THE CUSTOMER REPORTED THAT SMALL CRACKS WERE OBSERVED IN THE COUPLING PIECE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WASN'T ANY LEAK FROM THE CANNULA, OR FROM THE CONNECTION BETWEEN A CANNULA AND A CONNECTOR. THERE WAS NO PATIENT BLOOD LOSS. NO TRANSFUSION WAS REQUIRED. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS DEVICE WAS BEING USED FOR AN ECMO PROCEDURE. THERE WAS NO INJURY RELATED TO THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841090 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