BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3

    MDR report key: 9643843 · Received January 29, 2020

    Report

    Report Number
    3011468686-2019-00004
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    December 26, 2019
    Report Date
    January 28, 2020
    Manufacturer
    MC3 INC.
    Product Code
    DWF
    UDI-DI
    10854916006727
    PMA / PMN Number
    K132451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE END OF A CARDIOPULMONARY BYPASS SURGERY, A NEW CANNULA WAS BEING PREPARED FOR AN ECMO PROCEDURE. ECMO IS LONG-TERM USE AND IT IS OFF-LABEL USE FOR THIS DEVICE. IT WAS NOTICED BY THE CUSTOMER THAT THE CONNECTOR HAD BECOME SEPARATED AT THE GLUE JOINT OF THE CANNULA DURING THE SET UP FOR THE ECMO PROCEDURE. THE CANNULA WAS SUBSEQUENTLY UTILIZED FOR THE ECMO PROCEDURE WITH A DIFFERENT TUBING CONNECTOR. IT IS NOT POSSIBLE TO ANALYZE THE ACTUAL DEVICE INVOLVED IN THIS REPORT BECAUSE IT WAS NOT RETURNED TO MC3 FOR EVALUATION. MC3 HAS MANUFACTURING CONTROLS OF THIS BOND JOINT AND ALL INFORMATION REVIEWED AND TESTING RESULTS CONFIRM THAT SPECIFICATIONS ARE MET. AN IN DEPTH REVIEW OF PRODUCTION DATA, TREND DATA, RECORDS AND TESTING DID NOT UNCOVER ANY ROOT CAUSE OF BOND STRENGTH VARIATION THAT COULD HAVE CAUSED THE MALFUNCTION. WITH EXCESSIVE FORCE, IT IS POSSIBLE TO BREAK THE GLUE JOINT BOND PRIOR TO DISCONNECTION OF THE TUBING TO BARB CONNECTION. A FORCE MAY HAVE BEEN APPLIED TO THE BOND JOINT GREATER THAN THE 20 POUND SPECIFICATION LIMIT. THE ROOT CAUSE OF THE PROBLEM EXPERIENCED REMAINS INCONCLUSIVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MALFUNCTION TO THE DISTRIBUTOR ON 12/27/2019. THE DISTRIBUTOR FORWARDED INFORMATION ABOUT THIS MALFUNCTION ON 12/31/2019 TO MC3 INC. THE CUSTOMER DESCRIBED THE FOLLOWING: DURING THE PREPARATION FOR AN ECMO CASE USING THE MC3 SOFT FLOW ANGLED TIP ARTERIAL CANNULA, WHEN THE CANNULA WAS CLAMPED BETWEEN WIRE WINDING AND CONNECTOR, THE DEVICE SEPARATED AT THE CONNECTION OF THE CANNULA BODY AND THE CONNECTOR. AFTER THE SEPARATION OCCURRED, THE CANNULA WAS LEFT IN PLACE WITH A DIFFERENT CONNECTOR USED TO CONNECT THE CANNULA TO THE PERFUSION CIRCUIT. THE PATIENT IS ON ECMO WAITING FOR A TRANSPLANT. THERE IS NO ALLEGATION THAT THIS SEPARATION CAUSED ANY ISSUES FOR THE PATIENT. THE DEVICE WAS USED AT THE START OF THE ECMO CASE. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS RE-CANNULATED SO THE ORIGINAL CANNULA IS NO LONGER IN THE ECMO CIRCUIT. THE HOSPITAL DID NOT RELEASE THE CANNULA. THE MALFUNCTION OCCURRED POST CPB PROCEDURE AND DURING THE SET UP FOR THE ECMO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108305 MC3 CARDIOVASCULAR CANNULA DWF MC3 INC. 7071 1802100 10854916006727

    Patients

    Seq Age Sex Outcome Treatment
    1