BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D902 LILLIPUT ECMO M PHISIO

    MDR report key: 14043083 · Received April 7, 2022

    Report

    Report Number
    9680841-2022-00021
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 9, 2022
    Report Date
    July 12, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED D902 LILLIPUT ECMO M PHISIO (CATALOG NUMBER 050511, LOT 2110200045) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050511 IS SIMILAR TO THE LILLIPUP PMP, LILLIPUT PMP INTEGRATED OXYGENATOR CATALOGUE 050577, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE PRODUCT ITEM 050511 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE LILLIPUP PMP, LILLIPUT PMP INTEGRATED OXYGENATOR CATALOGUE 050577, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K151713). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP ITALIA MANUFACTURES THE LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6), BELGIUM. THE OXYGENATOR IS AVAILABLE AND HAS BEEN REQUESTED FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RETURNED.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT OF WATER SPILLAGE FROM TOP AREA OF LILLIPUT OXYGENATOR OCCURRED WHEN PRIMING THE WATER COMPARTMENT WHILE USING THE DEDICATED HOLDER WITH INTEGRATED WATER PATH COUPLED WITH HEATER COOLER SYSTEM. THE COMPLAINED LILLIPUT OXYGENATOR WAS RETURNED TO LIVANOVA. VISUAL INSPECTION OF THE STAINLESS STEEL COILED CORRUGATED TUBE COMPOSING THE HEAT EXCHANGER FOUND NO EVIDENT DAMAGE. SEPARATE LEAK TESTS OF THE BLOOD AND WATER COMPARTMENTS CONFIRMED THE LILLIPUT OXYGENATOR WAS INTEGER AND NO LEAK FROM ANY COMPARTMENT COULD BE REPRODUCED DURING OUR LABORATORY TEST. VERIFICATION OF MANUFACTURING RECORDS CONFIRMED THAT INVOLVED DEVICE WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. REVIEW OF LIVANOVA COMPLAINTS DATABASE REVEALED ONE SIMILAR EVENT RELATED TO THE SAME LOT OF LILLIPUT OXYGENATOR. INVESTIGATION OF THAT SIMILAR EVENT SUGGESTED THE LILLIPUT OXYGENATOR WAS INTEGER AND THE LEAK WAS MOST LIKELY RELATED TO DAMAGED OXYGENATING FIBER. BASED ON THE ABOVE INFORMATION, THE LEAKAGE EVENT FACED BY CUSTOMER COULD BE DUE TO DEFECTIVE HOLDER AND/OR WEAR OF O-RINGS AND/OR INCORRECT CONNECTION BETWEEN HOLDER AND LILLIPUT BY USER. INFACT, THE LEAKPROOF FEATURE OF THE WATER PATH IS GUARANTEED BY THE CORRECT COUPLING OF THE HEAT EXCHANGER WITH THE HOLDER, FURTHER SEALED BY TWO O-RINGS PRESENT ONE AT THE BASE AND ONE AT THE HEAD OF THE HOLDER. THE RISK IS IN THE ACCEPTABLE REGION. NO ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED A REPORT OF LEAKAGE FROM A LILLIPUT 2 ECMO WHERE FLUID IS COMING OUT OF THE WATER CONNECTIONS DURING PRIMING. THE ISSUE OCCURRED PRIOR TO PATIENT INVOLVEMENT. ACCORDING TO INFORMATION, PRIMING IS PERFORMED FOR 6 HOURS UP TO 15 DAYS.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341321 D902 LILLIPUT ECMO M PHISIO OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2110200045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown