BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 SOFT-FLOW AORTIC CANNULA

    MDR report key: 14364431 · Received May 11, 2022

    Report

    Report Number
    3011468686-2022-00006
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 11, 2022
    Manufacturer
    MC3 INC.
    Product Code
    DWF
    UDI-DI
    10854916006321
    PMA / PMN Number
    K132451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE DEVICE WAS NOT RETURNED, THE RESULTS OF THE INVESTIGATION COULD NOT CONFIRM THE DIRECT CAUSE OF THE CONNECTOR SEPARATING FROM THE CANNULA BODY. THE CUSTOMER MAY HAVE ADDED FORCE TO BREAK THE CONNECTOR BOND BUT THIS IS UNKNOWN. THE LOT RECORD REVIEW INDICATES THAT ALL 6394 DEVICES OF LOT 1911156 MET SPECIFICATION. THE TUBING HAD BEEN REMOVED FROM THE BARB CONNECTOR WHICH REQUIRES FORCE. AN IN-DEPTH REVIEW OF PRODUCTION DATA, TREND DATA, RECORDS, AND TESTING OF OTHER SOFT-FLOW DEVICES FROM THIS LOT 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 WHILE DISCONNECTING TUBING FROM THE CIRCUIT. A FORCE MAY HAVE BEEN APPLIED TO THE BOND JOINT GREATER THAN THE SPECIFICATION LIMIT. THE INVESTIGATION OF THIS ISSUE WAS COMPLETED THAT DID NOT REVEAL ANY SIGNIFICANT FINDING RELATED TO THE MANUFACTURE OF THIS LOT OR ANY OTHER SOFT-FLOW LOT THAT WOULD INDICATE A CAUSE OF BOND FAILURE OTHER THAN FORCES GREATER THAN THE SPECIFIED BOND STRENGTH.

    Description of Event or Problem · 0

    DISTRIBUTOR RECEIVED INFORMATION THAT AFTER USE OF A MC3 6394 SOFT FLOW CANNULA FOR CARDIOPULMONARY BYPASS SURGERY, IT WAS REPORTED THAT THE CONNECTOR WAS DETACHED. THE CONNECTOR BROKE OFF THE CANNULA BODY WHEN DISCONNECTING FROM THE EXTRACORPOREAL CIRCUIT. THIS OCCURRED POST SURGERY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171414 MC3 SOFT-FLOW AORTIC CANNULA ARTERIAL CANNULA DWF MC3 INC. 6394 1911156 10854916006321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown