BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LILLIPUT

    MDR report key: 16751633 · Received April 17, 2023

    Report

    Report Number
    9680841-2023-00012
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 19, 2023
    Report Date
    September 28, 2023
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINED LILLIPUT OXYGENATOR UNITS WERE RETURNED AND INVESTIGATED AT LIVANOVA. DURING THE DRYING AT PRELIMINARY WASH STEPS (BEFORE ACTUAL TEST), FOAM WAS OBSERVED FROM THE GAS ESCAPE PORT OF BOTH UNITS. SUCH A BEHAVIOR IS CONSISTENT WITH EXTENDED HYDROPHILIZATION OF THE OXYGENATOR FIBERS AND PLASMA BREAKTHROUGH IN GAS SIDE WHICH RESULTED IN PLASMA LEAKAGE AT CUSTOMER'S SITE, IN LINE WITH THE COMPLAINED EVENT. CONDITIONS OF RETURNED DEVICES DID NOT ALLOW TO PERFORM ANY FURTHER ANALYSIS OF GAS EXCHANGE PERFORMANCE. DHR REVIEW CONFIRM THE DEVICE WAS RELEASED CONFORMING TO PRODUCT SPECIFICATION. ANALYSIS OF LIVANOVA COMPLAINTS DATABASE REVEALED NO FURTHER SIMILAR CASES AFFECTING INVOLVED BATCH. NO ADVERSE TREND FOR LILLIPUT DEVICES ASSEMBLED WITH SAME ITEM OF FIBER WAS REGISTERED. AS CONFIRMATION, THE CUSTOMER ALREADY USED 96 UNITS OF CLAIMED LILLIPUT OXYGENATOR LOT BEFORE THESE EVENTS AND NO SIMILAR CASE WAS EXPERIENCED. A POSSIBLE FIBER RAW MATERIAL DEFECT, ASSOCIATED WITH INCREASED POROSITY OF HOLLOW FIBER WHICH LET PLASMA TO POUR OUT OF FIBER THUS CREATING A BARRIER TO THE PASSAGE OF GAS THROUGH FIBER, CAN BE EXCLUDED SINCE NO FURTHER SIMILAR EVENT WAS RECORDED IN LAST 24 MONTHS AND NO OXYGENATOR ASSEMBLED WITH SAME LOT OF FIBER WAS COMPLAINED BY OTHER CUSTOMERS. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    A.1., A.3, A.5. D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED LILLIPUT 1 START OXYGENATOR (CATALOG NUMBER 050578) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050578 IS SIMILAR TO THE LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR CATALOGUED 05319, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER (B)(4). G.5. THE PRODUCT ITEM 050578 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR CATALOGUED 05319, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K953835). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. H.10. SORIN GROUP ITALIA MANUFACTURES THE LILLIPUT 1 START OXYGENATOR. THE INCIDENT OCCURRED IN ISRAEL. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. THROUGH FOLLOW UP WITH THE CUSTOMER, LIVANOVA WAS INFORMED THAT THE PROCEDURE LASTED 5 HOURS. THE REPLACEMENT OF THE OXYGENATOR WAS PERFORMED OFF OF THE AORTIC CROSS CLAMP APPLICATION AND WAS COMPLETED IN ABOUT TWO MINUTES. AS FOR THE COOLING TREATMENT CONDUCTED, PERFUSIONIST CONFIRMED THAT IT WAS A ROUTINE CLINICAL PRACTICE. DURING A NORWOOD/SANO OPERATION SINCE IT REQUIRES CIRCULATORY ARREST AND ANTEGRADE CEREBRAL PERFUSION. NO ADDITIONAL MEDICAL INTERVENTION TO PREVENT OR PRECLUDE DEATH OR SERIOUS INJURY WAS THEREFORE ESTABLISHED. ANALYSIS OF BLOOD GAS REPORTS AND VISUAL EVIDENCE PROVIDED POINTED OUT THAT ARTERIAL PO2 VALUE DROPPED BELOW 60 MMHG FOR MORE THAN 3 MINUTES (FROM 12.19 WHERE PO2 WAS 27,8 MMHG TO 12.21 WHERE PO2 WAS 49 MMHG UP TO 12.23 WHEN OXYGENATOR WAS REPLACED). THE PATIENT WAS PLACED ON ECMO AT 15.17, ONE MINUTE AFTER THE END OF THE OPERATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INTIAL.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT TWO (2) HOURS AFTER ENTERING BYPASS FOR A NORWOOD PROCEDURE, THE PERFUSIONIST NOTICED LOW OXYGENATION VALUES AND A LEAK OF PLASMA OUT OF THE LILLIPUT OXYGENATOR GAS OUTLET. IT WAS DECIDED THAT THE PATIENT SHOULD BE COOLED AND THE OXYGENATOR TO BE REPLACED. PATIENT WAS PUT IN ECMO AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322409 LILLIPUT OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 050578 2205270026

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO Male