BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT CORONARY PERFUSION CANNULAE

    MDR report key: 8401367 · Received March 7, 2019

    Report

    Report Number
    9680841-2019-00010
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 5, 2019
    Report Date
    July 25, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED CANNULA WAS RETURNED TO LIVANOVA FOR INVESTIGATION. VISUAL INSPECTION CONFIRMED THE DISCONNECTION OF THE SILICONE CAP FROM THE TIP OF THE CANNULA. THIS IS THE UNIQUE UNIT OF THE AFFECTED BATCH COMPLAINED FOR DISCONNECTION. THE SILICONE CAP IS SUPPLIED TO LIVANOVA ALREADY CO-MOLDED ON THE TIP BY A LIVANOVA SUPPLIER. THE SUPPLIER HAS BEEN INFORMED AND INVOLVED FOR ROOT CAUSE INVESTIGATION. ACCORDING TO SUPPLIER AND LIVANOVA INVESTIGATION RESULTS, A ROUGH HANDLING OF THE CANNULA BY THE CUSTOMER CANNOT BE RULED OUT AS CONTRIBUTING FACTOR OF THE ROOT CAUSE. THE FREQUENCY OF THIS TYPE OF EVENT IS VERY LOW (INCREDIBLE = (B)(4). LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WERE NOT PROVIDED. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED CARDIOPLEGIA CANNULAE. THE COMPLAINED CARDIOPLEGIA CANNULAE (CATALOG NUMBER P616-40/J, LOT 1802270189) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE CARDIOPLEGIA CANNULAE ITEM P616-40/J IS SIMILAR TO THE CARDIOPLEGIA CANNULAE ITEM P616-40, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE AGE OF THE CANNULA WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. (B)(4). THE CARDIOPLEGIA CANNULAE ITEM P616-40/J IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE CARDIOPLEGIA CANNULAE ITEM P616-40, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K022280). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CARDIOPLEGIA CANNULAE. PER EXEMPTION NUMBER E2016005. THE INVOLVED CARDIOPLEGIA CANNULAE HAS BEEN RECEIVED AND SENT TO DECONTAMINATION AS PER (B)(4) PROCEDURE ON BLOOD CONTAMINATED GOODS. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT YET RETURNED FROM DECONTAMINATION.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE TIP OF THE CARDIOPLEGIA CANNULAE GOT DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194149 STOCKERT CORONARY PERFUSION CANNULAE CARDIOPLEGIA CANNULAE, ANTEGRADE CORONARY OSTIA PERFUSION DWF SORIN GROUP ITALIA SRL 1802270189

    Patients

    Seq Age Sex Outcome Treatment
    1