BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EOS PMP, EOS PMP INTEGRATED

    MDR report key: 11776993 · Received May 5, 2021

    Report

    Report Number
    9680841-2021-00011
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    March 5, 2021
    Report Date
    June 15, 2021
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE DIDECO EOS ECMO OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM C24520; LOT 2011300110) 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 COMPLAINED DIDECO EOS ECMO OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE PRODUCT ITEM 03486 - DIDECO EOS ECMO IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE EOS PMP, EOS PMP INTEGRATED ITEM 050576, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K150489). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE DIDECO EOS ECMO OXYGENATOR. THE INCIDENT OCCURRED IN BE (B)(6). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN 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.

    Additional Manufacturer Narrative · 1

    LIVANOVA RECEIVED A REPORT REGARDING A BLOOD LEAK FROM THE HANSEN CONNECTORS OF THE WATER COMPARTMENT OF AN EOS ECMO OXYGENATOR. THE OXYGENATOR WAS REPLACED. THERE IS NO REPORT OF ANY PATIENT INJURY. THE OXYGENATOR WAS RECEIVED A LIVANOVA FACILITY FOR INVESTIGATION. INITIAL VISUAL INSPECTION DID NOT IDENTIFY ANY OBVIOUS DAMAGE OR NON-CONFORMITY. TO INVESTIGATE THE CLAIMED ISSUE, THE BLOOD COMPARTMENT OF THE OXYGENATOR WAS FILLED WITH WATER AND PRESSURIZED. THE LEAK TEST COULD REPRODUCE THE LEAK FROM THE HANSEN CONNECTOR FROM WATER IN THE BLOOD COMPARTMENT THUS CONFIRMING THE PRESENCE OF A COMMUNICATION (DAMAGE/HOLE) IN THE METAL SHEET BETWEEN WATER AND BLOOD COMPARTMENTS. THE OXYGENATOR WAS AUTOPSIED, AND THE METAL SHEET WAS SECTIONED TO IDENTIFY THE POINT WHERE THE SHEET WAS DAMAGED. THE HOLE WAS IDENTIFIED IN THE CORRESPONDENCE OF A METAL SHEET FOLDING. NO TRACE OF CORROSION OR METAL DEGRADATION WAS FOUND IN THE DAMAGED AREA. DHR OF THE COMPLAINED EOS ECMO DID NOT IDENTIFY ANY ISSUE. ALL (100%) OF THE UNITS ARE LEAK TESTED DURING MANUFACTURING: THE COMPLAINED OXYGENATOR HAS SUCCESSFULLY PASSED THE LEAK TEST. REVIEW OF THE LIVANOVA COMPLAINT DATABASE DID NOT IDENTIFY ANY OTHER SIMILAR EVENT RELEVANT TO THE LOT OF OXYGENATOR OR HEAT EXCHANGER MODULE THUS EXCLUDING ANY SYSTEMATIC ISSUE. TO INVESTIGATE THE POSSIBLE ROOT CAUSE OF COMMUNICATION BETWEEN WATER AND BLOOD COMPARTMENTS, THE (B)(4) WAS OPENED. RESULTS OF THE INVESTIGATION SUGGESTED THE MOST PROBABLE ROOT CAUSES ARE RESIDUAL PROCESSING STRESS ASSOCIATED TO COLD METAL SHEET DEFORMATION COMBINED BY CORROSION, PRESENCE OF SAND RESIDUE AFTER SANDING PROCESS AND DEGRADATION OF COMPACTING SURFACE. DESPITE THE RISK IS ACCEPTABLE AND THE FREQUENCY OF THIS TYPE OF EVENT IS LOW (INCREDIBLE), TO FURTHER DECREASE THE OCCURRENCE, LIVANOVA HAS PLANNED TO START TO TREAT METAL SHEET OF EOS ECMO&PMP OXYGENATORS WITH PRIMER TO IMPROVE THE CORROSION RESISTANCE. THE VALIDATION ACTIVITIES HAVE BEEN COMPLETED AND IMPLEMENTATION OF THIS ACTION IS PLANNED BY END 2021. LIVANOVA INVESTIGATION COULD NOT IDENTIFY ANY SPECIFIC ROOT CAUSE. BASED ON THE ABOVE, IT CANNOT BE RULED OUT THAT MOST PROBABLE ROOT CAUSE IS A MANUFACTURING DAMAGE THAT IS NOT DETECTABLE DURING MANUFACTURING TEST. THE DAMAGE EVOLVES AFTER DEVICE RELEASE WITH THE CONTRIBUTION OF SOME OTHER FACTORS SUCH AS CORROSION, RESIDUAL SAND AND DEGRADATION. LIVANOVA HAS IDENTIFIED ACTION TO IMPROVE THE CORROSION RESISTANCE OF THE METAL SHEET. AS NO SPECIFIC ROOT CAUSE WAS IDENTIFIED AND THE PROBABILITY IS ACCEPTABLE, NO OTHER ACTION WAS DEEMED NECESSARY. LIVANOVA WILL MAINTAIN MONITORING THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, AT THE BEGIN OF AN ECMO PROCEDURE TO A COVID PATIENT, BLOOD LEAKAGE FROM BLOOD COMPARTMENT TO WATER COMPARTMENT. THE MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672881 EOS PMP, EOS PMP INTEGRATED OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2011170050

    Patients

    Seq Age Sex Outcome Treatment
    1