BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    MDR report key: 15426594 · Received September 15, 2022

    Report

    Report Number
    9680841-2022-00040
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    June 23, 2022
    Report Date
    October 26, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 OXYGENATOR (CATALOG NUMBER 05318) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 05318 IS SIMILAR TO THE D901 DIDECO LILLIPUT OXYGENATOR 05316, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE PRODUCT ITEM 05318 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE D901 DIDECO LILLIPUT OXYGENATOR 05316, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K010478). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP ITALIA MANUFACTURES THE D901 DIDECO LILLIPUT OXYGENATOR. THE INCIDENT OCCURRED IN CHINA. FOLLOW UP WITH THE CUSTOMER CLARIFIED THAT VISUAL EXAMINATION OF RECEIVED VIDEO PROVIDED CLEAR EVIDENCE OF NO FLOW CONDITION INSIDE THE RED SAMPLING LINE CONNECTED TO ARTERIAL FEMALE LUER PORT OF OXYGENATOR AND MANAGED BY 3-WAYS MANIFOLD CONTROL GROUP. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, LIVANOVA LEARNED THAT THE OBSTRUCTION PROBLEM WAS DETECTED WHEN TAKING THE FIRST BLOOD SAMPLE FOR ARTERIAL BLOOD GAS ANALYSIS (ABGA). THE PROCEDURE WAS INTERRUPTED FOR MORE THAN 3 MINUTES TO ALLOW THE MANEUVERS OF OXYGENATOR REPLACEMENT. AT THE SUBMISSION OF THE CASE, EXPLANATORY VIDEO WAS PROVIDED BY THE CUSTOMER SHOWING NO FLOW IN THE RED SAMPLING LINE CONNECTED TO ARTERIAL FEMALE LUER PORT OF OXYGENATOR (AND MANAGED BY 3-WAYS MANIFOLD CONTROL GROUP). DESPITE COMPLAINED OXYGENATOR WAS DISCARDED AND COULD NOT BE INVESTIGATED, THE PROBLEM IS CONFIRMED BASING ON AVAILABLE VIDEO. REVIEW OF LIVANOVA COMPLAINTS DATABASE REVEALED THAT BATCH CONCERNED WAS INVOLVED IN ONE FURTHER EVENT FOR SAME ISSUE OCCURRED AT THIS CUSTOMER FACILITY ON A DIFFERENT DAY. INVESTIGATION PREVIOUS OF SIMILAR EVENT COULD REPRODUCE THE REPORTED SAMPLING PORT FLOW PROBLEM. AUTOPSY OF THE SAMPLING PORT POINTED OUT THAT THE INSERT BODY OF THE ONE-WAY VALVE IN THE SAMPLING PORT WAS DAMAGED. LILLIPUT OXYGENATORS ARE ASSEMBLED BY A LIVANOVA SUPPLIER (MEDIPRO). A DEDICATED NON-CONFORMITY REPORT HAS BEEN ISSUED TO INVESTIGATE THE ONE-WAY VALVE ASSEMBLY PROCESS BY THE SUPPLIER, FOCUSING ON THE COUPLING OF (I) THE INSERT WITH MEMBRANE SILICONE VALVE AND (II) SAMPLING LINE WITH THE OXYGENATOR PORT AFTER THE INSERT IS MANUALLY POSITIONED ABOVE THE VALVE. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING A PROCEDURE USIND D901 LILLIPUT OXYGENATOR, THE ARTERIAL SAMPLING PORT WAS BLOCKED. MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR AND THE CHANGE-OUT LASTED MORE THAN 3 MINUTES. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2411328 DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2004270241

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Male