BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR

    MDR report key: 20862138 · Received December 6, 2024

    Report

    Report Number
    9680841-2024-00032
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    October 25, 2024
    Report Date
    December 24, 2024
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THROUGH FOLLOW-UP COMMUNICATION, THE CUSTOMER CLARIFIED THAT THE LEAK ACTUALLY ORIGINATED FROM THE SUPPORT (HOLDER) OF THE LILLIPUT OXYGENATOR, NOT FROM THE DEVICE ITSELF. IN FACT, DURING THE PRE-BYPASS, IT WAS IDENTIFIED THAT THE SUPPORT OF THE LILLIPUT OXYGENATOR WAS NOT ADEQUATELY SEALED, RESULTING IN A WATER LEAKAGE. TO ADDRESS THIS ISSUE, THE OXYGENATOR WAS PROMPTLY REPLACED WITH A KIDS OXYGENATOR WHICH USES A DIFFERENT TYPE OF SUPPORT. THIS REPLACEMENT WAS CONDUCTED PRIOR TO THE CLAMPING OF THE AORTA. THE NEW EQUIPMENT FUNCTIONED PERFECTLY, ALLOWING THE SURGERY TO CONTINUE WITHOUT ANY RISK TO THE PATIENT. THEREFORE, BASED ON THE ABOVE INFORMATION, THE EVENT HAS BEEN RE-ASSESSED AS NOT REPORTABLE. IT WAS INDEED CONFIRMED THAT THE LEAKAGE WAS COMING FROM THE LILLIPUT HOLDER WHICH INTEGRATES THE WATER PATH OF THE LILLIPUT OXYGENTOR, AND THAT THE REPLACEMENT OF THE OXYGENATOR OCCURRED IN THE PRE-BYPASS PHASE, PRIOR TO CLAMPING THE AORTA OF THE PATIENT.

    Additional Manufacturer Narrative · 0

    A.1-A.5. PATIENT INFORMATION WERE NOT PROVIDED. D.4. . THE COMPLAINED LILLIPUT 1 OXYGENATOR (CATALOG NUMBER 050596) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050596 IS SIMILAR TO THELILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR ITEM 05319 , WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). G.5. THE PRODUCT ITEM LILLIPUT 1 OXYGENATOR (CATALOG NUMBER 050596) IS NOT DISTRIBUTED IN THE USA, AND IT IS SIMILAR TO THE LILLIPUT 1 OXYGENATOR (CATALOG NUMBER 05319), WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K953835). H.11. SORIN GROUP ITALIA MANUFACTURES THE LILLIPUT 1 OXYGENATOR. 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 INITIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECIEVED A REPORT THAT THE WATER TUBE CONNECTOR CAUSED A LEAK FROM A LILLIPUT 1 OXYGENATOR (CRACK AND RUPTURE OF THE MEMBRANE). MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR DURING THE PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292010 LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 050596 2206300082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown