BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARXT TUBING AND CONNECTORS

    MDR report key: 12039047 · Received June 22, 2021

    Report

    Report Number
    1718850-2021-00034
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 24, 2021
    Report Date
    August 4, 2021
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWE
    UDI-DI
    00803622136245
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CUSTOMER CONFIRMED THE PRESENCE OF A CUT IN THE TUBING OF THE REVOLUTION OUTLET PUMP UNDER THE TIE BAND. NO DISCONNECTION OCCURRED. NO IMPACT ON THE PATIENT. THE DHR REVIEW CONFIRMED THE CIRCUIT WAS RELEASED CONFORMING TO PRODUCT SPECIFICATIONS. THE LOT WAS MADE OF 22 UNITS AND ONLY ONE WAS CLAIMED FOR THIS ISSUE. ANALYSIS OF LIVANOVA COMPLAINT DATABASE DID NOT IDENTIFY ANY OTHER SIMILAR EVENT. THEREFORE, THE CASE IS AN ISOLATED EVENT. THE COMPLAINED UNIT WAS NOT MADE AVAILABLE FOR INVESTIGATION AS IT WAS DISPOSED BY THE CUSTOMER. IT WAS NOT POSSIBLE TO CLARIFY IF THE DEFECT OCCURRED DURING THE PROCEDURE OR IF WAS UN-NOTICED DURING THE UNPACKING. LIVANOVA INVESTIGATION COULD NOT IDENTIFY THE ROOT CAUSE. THEREFORE, A MANUFACTURING ISSUE COULD NOT BE EXCLUDED SINCE IT WAS NOT POSSIBLE TO CONFIRM WHETHER THE CUT WAS RELATED TO WEAKNESS OF THE TUBING OR TO A HUMAN ERROR CAUSED BY THE LIVANOVA MANUFACTURING OPERATOR CUTTING THE TUBING DURING THE ASSEMBLY. THE RISK IS ACCEPTABLE. LIVANOVA WILL MAINTAIN MONITORING THE MARKET. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION HAS BEEN PROVIDED. THE COMPLAINED CIRCUIT HAS BEEN REQUESTED AND NOT YET RETURNED TO LIVANOVA ARVADA (MANUFACTURER). LIVANOVA USA INC MANUFACTURES THE COMPLAINED CIRCUIT. THE INCIDENT OCCURRED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA USA INC. HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE TUBING PRESENTED A SPLIT ON CONNECTOR. THE TUBING WAS CUT OUT AND PROCEDURE COMPLETED WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935073 SMARXT TUBING AND CONNECTORS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC 2110500036 00803622136245

    Patients

    Seq Age Sex Outcome Treatment
    1