BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN LIFEKIT D905 EOS ECMO

    MDR report key: 12632482 · Received October 14, 2021

    Report

    Report Number
    9680841-2021-00028
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 14, 2021
    Report Date
    December 10, 2021
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED EOS ECMO OXYGENATOR (CATALOG NUMBER 05469 - SORIN LIFEKIT D905 EOS ECMO, LOT 2009090064) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 05469 IS SIMILAR TO THE ITEM 050576 - EOS PMP, EOS PMP INTEGRATED OXYGENATOR, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE PRODUCT ITEM 05469 - SORIN LIFEKIT D905 EOS ECMO IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE ITEM 050576 - EOS PMP, EOS PMP INTEGRATED OXYGENATOR, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K150489). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP (B)(4) MANUFACTURES THE ITEM 05469 - SORIN LIFEKIT D905 EOS ECMO. THE INCIDENT OCCURRED IN (B)(6). SORIN GROUP (B)(4) HAS NOT BEEN INFORMED IF THE COMPLAINED OXYGENATOR IS AVAILABLE FOR INVESTIGATION. DURING FOLLOW UP INFORMATION WITH THE CUSTOMER LIVANOVA HAS BEEN INFORMED THAT: LEAK WAS DETECTED WHEN PATIENT WAS CONNECTED TO THE HLM. THERE IS NO IMPACT ON THE PATIENT, THE EOS ECMO OXYGENATOR HAS BEEN DISPOSED. EOS ECMO OXYGENATOR HAS BEEN PRIMED FOR LESS THAT 24 HOURS. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    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 ISSUE WAS CONFIRMED FROM EXPLANATORY PHOTOGRAPHIC EVIDENCE SHOWING BLOOD IN THE HANSEN CONNECTORS. CUSTOMER REPORTED THAT PRIMING PHASE WAS PERFORMED ACCORDING TO IFU. DHR OF THE COMPLAINED EOS ECMO DID NOT IDENTIFY ANY ISSUE. THE UNIT SUCCESSFULLY PASSED THE LEAK TEST PERFORMED ON (B)(4) OF THE UNITS DURING MANUFACTURING AND BEFORE RELEASE. 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. COMPLAINED OXYGENATOR WAS NOT MADE AVAILABLE FOR INVESTIGATION. TO INVESTIGATE THE POSSIBLE ROOT CAUSES OF COMMUNICATION BETWEEN WATER AND BLOOD COMPARTMENTS, LIVANOVA OPENED A CAPA PROJECT. RESULTS OF THE INVESTIGATION SUGGESTED THE MOST PROBABLE ROOT CAUSES ARE RESIDUAL PROCESSING STRESS ASSOCIATED TO COLD METAL SHEET DEFORMATION COMBINED BY (I) CORROSION, (II) PRESENCE OF SAND RESIDUE AFTER SANDING PROCESS AND (III) DEGRADATION OF COMPACTING SURFACE. 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. DESPITE THE RISK IS ACCEPTABLE AND THE FREQUENCY OF THIS TYPE OF EVENT IS LOW (INCREDIBLE), TO FURTHER DECREASE THE OCCURRENCE, LIVANOVA HAS STARTED TO TREAT METAL SHEET OF EOS ECMO&PMP OXYGENATORS WITH PRIMER TO IMPROVE THE CORROSION RESISTANCE. LIVANOVA HAS VALIDATED AND IMPLEMENTED IN THE CURRENT MANUFACTURING PROCESS A STEEL SURFACE COATING. THE FIRST LOT OF EOS ECMO OXYGENATOR ASSEMBLED WITH NEWLY TREATED HEAT EXCHANGER METAL SHEET HAS BEEN MANUFACTURED IN OCTOBER 2021. THE COMPLAINED OXYGENATOR WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THE PRIMER TREATMENT. LIVANOVA HAS IDENTIFIED ACTION TO IMPROVE THE CORROSION RESISTANCE OF THE METAL SHEET. NO OTHER SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY LIVANOVA WILL KEEP MONITORING THE MARKED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING SUPPORT, BLOOD WAS IDENTIFIED IN EXITING FROM WATER CONNECTORS. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530594 SORIN LIFEKIT D905 EOS ECMO OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2009090064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown