BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE SMARXT TUBING AND CONNECTORS

    MDR report key: 14110070 · Received April 14, 2022

    Report

    Report Number
    1718850-2022-00028
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 10, 2022
    Report Date
    June 6, 2022
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWE
    UDI-DI
    00803622137440
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA USA INC MANUFACTURES THE CONVENIENCE PACK ADULT PUMP AND TABLE PACK MONTFIORE MED CTR (B)(6). THE INCIDENT OCCURRED IN (B)(6), UNITED STATES. THE INVOLVED DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. ON 08/APR/2022, LIVANOVA SUBMITTED THE MEDWATCH (LIVANOVA COMPLAINT REF 2022-01587) AND WE HAVE RECEIVED THE 1ST AND 2ND ACK (B)(4). HOWEVER, AFTER 2 DAYS SINCE SUBMISSION, NO 3RDACK HAD NOT BEEN RECEIVED YET. ON 11/APR/2022, LIVANOVA CONTACTED CESUB HELP DESK (B)(4) TO REQUEST INFORMATION ON SUBMISSION RESULT. ON 13/APR/2022, CESUB HELP DESK RESPONDED THAT THE SUBMISSION WITH THE CORE ID (B)(4) COULD NOT BE PROCESSED AS THERE SEEMS TO BE AN ISSUE: XML IS INVALID AGAINST SCHEMA. PLEASE CHECK YOUR SUBMISSION FOR ANY ERRORS, REPACKAGE IT PROPERLY AND RESUBMIT IT. ON 14/APR/2022, LIVANOVA IS RESUBMITTING THE MEDWATCH.

    Additional Manufacturer Narrative · 0

    AT THE SUBMISSION OF THE CASE, THE CUSTOMER PROVIDES A PICTURE CONFIRMING THE REPORTED MIS-ASSEMBLY. THE DHR REVIEW HIGHLIGHTED THAT CLAIMED LOT WAS RELEASED AS CONFORMING TO PRODUCT SPECIFICATIONS. A REVIEW OF THE LIVANOVA COMPLAINTS DATABASE REVEALED THAT A PREVIOUS SIMILAR EVENT OCCURRED ON THIS CIRCUIT ITEM CODE. BASED ON THE ABOVE, LIVANOVA BELIEVES THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS A MANUFACTURING OPERATOR ERROR DURING THE ASSEMBLY PHASE OF THIS CIRCUIT. THE PERSONNEL WILL BE INVOLVED IN A DEDICATED TRAINING MEETING. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA USA INC HAS BEEN INFORMED THAT, DURING PRIMING OF THE CIRCUIT, THE MEDICAL TEAM IDENTIFIED THAT WHITE AND YELLOW CLAMPS OF THE CARDIOPLEGIA CIRCUIT WERE SWAPPED WITH THE RESPECT TO THE TECHNICAL DRAWING. THERE IS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210920 COBE SMARXT TUBING AND CONNECTORS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC 2203500080 00803622137440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown