BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RE

    MDR report key: 8453401 · Received March 26, 2019

    Report

    Report Number
    9680841-2019-00015
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    February 15, 2019
    Report Date
    May 28, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN SALAMANCA, SPAIN. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). MICROSCOPIC INSPECTION OF THE RETURNED OXYGENATOR MODULE CONFIRMED THE PRESENCE OF A DROP OF DRIED UV RESIN BY THE ARTERIAL FILTER. ACCORDING TO LIVANOVA SOP, UV RESIN IS USED DURING THE MANUFACTURING OF LID OF THE ARTERIAL FILTER. SIMULATED USE TEST OF THE DEVICE CONFIRMED THAT, IN STANDARDS CONDITIONS, THE DRIED DROP DO NOT DETACH FROM THE ARTERIAL FILTER SURFACE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE PRESENCE OF THE DROP OF DRIED UV RESIN IS ASCRIBABLE TO A HUMAN ERROR DURING THE MANUFACTURING AND DURING THE SUBSEQUENT VISUAL INSPECTION STEPS THAT SHOULD HAVE IDENTIFIED THE DROP AND DISCARDED THE UNIT. TO PREVENT REOCCURRENCE, THE MANUFACTURING FLOOR WILL BE RETRAINED. THE FREQUENCY OF THIS TYPE OF EVENT IS LOW. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN00508, LOT 1805290084) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). PMA/510 (K):THE COMPLAINED INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050703) IS REGISTERED IN THE USA (510(K) NUMBER: K130433). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. PER EXEMPTION NUMBER E2016005. THE INVOLVED DEVICE HAS BEEN RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING CIRCUIT SET UP, PARTICULATE WAS DETECTED BY THE BLOOD OUTLET CONNECTOR OF THE INTEGRATED ARTERIAL FILTER OF AN INSPIRE 8F OXYGENATOR. THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246621 INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RE HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR DTZ SORIN GROUP ITALIA SRL 1805240007

    Patients

    Seq Age Sex Outcome Treatment
    1