BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EOS PMP, EOS PMP INTEGRATED

    MDR report key: 13860809 · Received March 23, 2022

    Report

    Report Number
    9680841-2022-00019
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 18, 2022
    Report Date
    May 24, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED THE DIDECO EOS ECMO OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (CATALOGUE C23812, LOT 2110290132) 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 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 COMPLAINED DIDECO EOS ECMO OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE COMPLAINED DIDECO EOS ECMO IS NOT DISTRIBUTED IN THE USA AND 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 CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE DIDECO EOS ECMO OXYGENATOR. THE INCIDENT OCCURRED IN (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 RECEIVED AT SORIN GROUP ITALIA FOR INVESTIGATION AND SENT TO GAMMA RAY DECONTAMINATION AS PER LIVANOVA PROCEDURE ON BLOOD CONTAMINATED GOODS. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    RETURNED DIDECO EOS ECMO WAS VISUALLY INSPECTED AND NO CRACK NOR OBVIOUS DAMAGE WAS VISIBLE. THE BLOOD COMPARTMENT OF THE OXYGENATOR WAS SUBJECTED TO LEAK INTEGRITY TEST BY FILLING THE COMPARTMENT WITH WATER AND PRESSURIZING THIS UP TO 1 BAR (MAXIMUM INTERNAL PRESSURE VALUE RECOMMENDED IN BLOOD PATH). NO LEAK COULD BE REPRODUCED FROM THE OXYGENATOR WATER CONNECTORS (HANSEN) CONFIRMING THE OXYGENATOR WAS INTEGER (NO COMMUNICATION BETWEEN BLOOD AND WATER COMPARTMENTS). LABORATORY TESTS COULD NOT CONFIRM THE REPORTED FAILURE. BASED ON AVAILABLE INFORMATION THE LEAKAGE OBSERVED BY THE CUSTOMER COULD BE RELATED TO A DAMAGED OXYGENATING FIBER. IN PRESENCE OF DAMAGE TO ONE CAPILLARY OF THE OXYGENATOR FIBER BUNDLE, FLUID (PRIMING OR BLOOD) ENTERS THE CAPILLARY AND DUE TO THE GAS FLOW DIRECTION POURS OUT IN THE GAS COMPARTMENT IN PROXIMITY TO GAS ESCAPE PORT. A POSSIBLE EXPLANATION FOR WHY THIS FAILURE WAS NO REPRODUCED IN LABORATORY IS THAT DRAINED BLOOD TRACES OR CLOTTING MAY HAVE PLUGGED THE INNER CORE OF THE FIBER, MAKING IT IMPOSSIBLE TO REPRODUCE THE DEFECT. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING SUPPORT, LEAK FROM THE EOS ECMO OXYGENATOR HEAT EXCHANGER WAS IDENTIFIED. THERE IS NO REPORT OF ANY PATIENT INJURY. DURING FOLLOW UP WITH THE CUSTOMER, IT WAS CONFIRMED THE LEAKAGE WAS BLOOD LEAKAGE AND IT WAS FROM THE WATER SIDE OF THE OXYGENATOR.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716537 EOS PMP, EOS PMP INTEGRATED OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2110270021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown