BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LILLIPUT 2

    MDR report key: 18065574 · Received November 3, 2023

    Report

    Report Number
    9680841-2023-00041
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    March 1, 2023
    Report Date
    August 19, 2024
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: PATIENT'S BLOOD GAS ANALYSIS (ARTERIAL SAMPLE), DATED (B)(6) 2023, WAS RECEIVED FROM THE CUSTOMER AND ANALYSED, CONFIRMING THAT BLOOD OXYGENATION (PO2 PARAMETER) WAS LOW. IN DETAIL, IT WAS 46 MMHG AT A TEMPERATURE OF 37°C AND 42 MMHG AT 35.8°C. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WERE NOT PROVIDED. D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED D 902 DIDECO LILLIPUT (CATALOG NUMBER 050579) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050579 IS SIMILAR TO THE D 902 DIDECO LILLIPUT ITEM 05320, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). G.5. THE PRODUCT ITEM 050579 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE D 902 DIDECO LILLIPUT ITEM 05320, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K971877). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. H.10. SORIN GROUP ITALIA MANUFACTURES THE D 902 DIDECO LILLIPUT. THE INCIDENT OCCURRED IN BRAZIL. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE PRESENT REPORT WAS SUBMITTED ON 02 NOVEMEBER 2023 AND IS BEING RESUBMITTED AFTER RECEIVING 3ACK ERROR (SECTION: E1 ERROR MESSAGE: (10) CHARACTERS ARE MAX. MESSAGE VALUE: (B)(4), SECTION E1 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE PUMPSHEET OF THE EVENT WAS NOT PROVIDED. THE REVIEW OF THE COMPLAINTS DATABASE REVEALED THAT NO SIMILAR EVENT WAS REPORTED FOR COMPLAINED LOT OF OXYGENATOR OUT OF 192 TOTAL MANUFACTURED UNITS, NEITHER CONCERNING TREND HAS BEEN IDENTIFIED. OXYGENATOR WAS AVAILABLE AND REQUESTED FOR INVESTIGATION. A FUNCTIONAL TEST WITH BOVINE BLOOD WAS RUN ON THE RETURNED SAMPLE AND THE PERFORMANCE LEVELS OF DEVICE IN TERMS OF O2 TRANSFER AND CO2 WERE FOUND ALIGNED WITH EXPECTED PERFORMANCE OUTCOMES FOR A BRAND-NEW DEVICE. BASED ON INVESTIGATION FINDINGS, NO DECAY IN THE BLOOD OXYGENATION CAPACITY OF INVOLVED OXYGENATOR WAS CONFIRMED. TAKING INTO ACCOUNT THE ABOVE FACTS, NO QUALITY DEVIATION OF THE DEVICE RELATED TO MANUFACTURING WAS ESTABLISHED. THEREFORE, IT CANNOT BE RULED OUT THAT THE MOST LIKELY ROOT CAUSE OF REPORTED EVENT WAS MULTIFACTORIAL, RESULTING FROM THE INTERACTION BETWEEN CLINICAL PROCEDURE, PATIENT CONDITIONS AND GAS-BLOOD SETTINGS. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT OF A FAILURE OF GAS EXCHANGE EVEN WITH HIGH AND OPTIMIZED GASES. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207851 LILLIPUT 2 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 050579 2204270166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown