BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    MDR report key: 13266438 · Received January 17, 2022

    Report

    Report Number
    9680841-2022-00006
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Date of Event
    December 20, 2021
    Report Date
    June 16, 2023
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WERE NOT PROVIDED. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED D901 DIDECO LILLIPUT PHISIO OXYGENATOR (CATALOG NUMBER 05319, LOT 2105030182) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 05319 IS SIMILAR TO THE D901 DIDECO LILLIPUT OXYGENATOR CATALOGUE 05318, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE COMPLAINED D901 DIDECO LILLIPUT PHISIO OXYGENATOR (CATALOG NUMBER 05319, LOT 2105030182) IS NOT DISTRIBUTED IN THE USA, SIMILAR TO THE D901 DIDECO LILLIPUT OXYGENATOR CATALOGUE 05318, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K953835). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP (B)(4) MANUFACTURES THE D901 DIDECO LILLIPUT PHISIO OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THE OXYGENATOR IS AVAILABLE AND HAVE BEEN REQUESTED FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE COMPLAINED OXYGENATOR WAS RETURNED TO LIVANOVA. VISUAL INSPECTION FOUND NO TRACE OF DRIED BLOOD NOR BIOLOGICAL DEPOSITS IN THE FIBERS OF THE OXYGENATOR. THE MECHANICAL INTEGRITY OF THE DEVICE WAS TESTED AT 1.5 BAR (THE MAXIMUM RECOMMENDED PRESSURE IN PRODUCT IFU IS 1 BAR) FOR 24 HOURS AND NO LEAK COULD BE DETECTED. INVOLVED DEVICE WAS FOUND TO BE LEAKPROOF WITHOUT ANY DEVIATION IDENTIFIED. INVESTIGATION IS ON-GOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    EXAMINATION OF PICTURE PROVIDED BY CUSTOMER SHOWED THE PRESENCE OF A SHUNTED AREA ALONG THE FIBER BUNDLE OF INVOLVED OXYGENATOR WHICH COULD POSSIBLY EXPLAIN THE DECREASED GAS EXCHANGE PERFORMANCES. A SUBSEQUENT TEST WITH BOVINE BLOOD WAS PERFORMED TO VERIFY ANY OBSTRUCTION OF BLOOD FLOW THROUGH OXYGENATOR FIBERS AS CAUSE OF THE DECREASED GAS EXCHANGE PERFORMANCES. THE OXYGENATOR WAS FUNCTIONALLY TESTED AS PER DESIGN SPECIFICATIONS. LABORATORY TEST COULD NOT REPRODUCE ANY INCREASED PRESSURE DROP ACROSS THE OXYGENATOR WHICH BEHAVED AS EXPECTED. BASED ON LABORATORY RESULTS, IT IS POSSIBLE TO CONCLUDE THAT OXYGENATOR FIBERS WERE INTEGER AND NOT OCCLUDED. REVIEW OF LIVANOVA COMPLAINTS DATABASE POINTED OUT NO OTHER SIMILAR ISSUE NOTIFIED FOR BATCH CONCERNED FROM THE MARKET. INVOLVED OXYGENATOR WAS ASSEMBLED WITH A UNIQUE LOT OF OXYGENATING FIBER WHICH WAS USED TO PRODUCE SEVERAL DIFFERENT BATCHES OF LILLIPUT OXYGENATORS DISTRIBUTED WORLDWIDE FOR WHICH NO SIMILAR EVENTS WERE EVER REPORTED, THIS EXCLUDING ANY DEFECT IN THE FIBRE RAW-MATERIAL. FINALLY, NO ADVERSE TREND ON LILLIPUT GAS PERFORMANCE ISSUE WAS CAPTURED BY LIVANOVA TRENDING. BASED ON ALL THE ABOVE, IT IS POSSIBLE TO EXCLUDE ANY STRUCTURAL/FUNCTIONAL ANOMALY OF THE OXYGENATOR FIBERS AS CAUSE OF THE REPORTED EVENT. THEREFORE, THE MOST LIKELY ROOT CAUSE OF REPORTED PERFORMANCE DROP WAS TRACED BACK TO UNEXPECTED BUILD UP OF BIOLOGICAL MATERIAL INSIDE OXYGENATOR FIBERS (PRESENCE OF A SHUNT), LEADING TO A REDUCTION OF EFFECTIVE AREA TO PERFORM GAS EXCHANGE AND A CONCOMITANT INCREASE OF GAS PATHWAY LENGTH TO PERFORM GAS EXCHANGE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT, AFTER GOING ON BYPASS, THE PO2 VALUE IN THE ARTERIAL PATIENT BLOOD WAS 38 MMHG AND COLOR WAS DARK. MEDICAL TEAM HAS CHANGED OUT THE GAS BLENDER AND INCREASED THE FIO2 TO 100%. THE COLOR OF ARTERIAL BLOOD REMAINED DARK. MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. AFTER THE CHANGE OUT, THE PO2 VALUE IN THE ARTERIAL PATIENT BLOOD WAS 214 MMHG. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960868 LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2105030182

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown