BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6 STERILE

    MDR report key: 18622092 · Received February 1, 2024

    Report

    Report Number
    9680841-2024-00004
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    October 25, 2023
    Report Date
    February 1, 2024
    Manufacturer
    SORIN GROUP ITALIA SRL.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 6 OXYGENATOR (CATALOG NUMBER 050713CN) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050713CN IS SIMILAR TO THE INSPIRE 6 OXYGENATOR 050713, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). G.5. THE PRODUCT ITEM 050713CN IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 6 OXYGENATOR 050713, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130209). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. H.10. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6 OXYGENATOR. THE INCIDENT OCCURRED IN BEIJING, CHINA. REVIEW OF LIVANOVA COMPLAINTS DATABASE REVEALED NO OTHER ANALOGUE CASES NOTIFIED FOR BATCH CONCERNED FROM THE MARKET. INVOLVED OXYGENATOR IS A STAND-ALONE DEVICE DELIVERED TO CUSTOMERS WITHOUT ANY VENOUS AND ARTERIAL LINES PRE-CONNECTED (INSTALLATION IS CHARGED TO CUSTOMER). PART WAS NOT RETURNED FOR TESTING NOR VISUAL EVIDENCE OF THE ISSUE WAS PROVIDED. AS PER DATA CURRENTLY AVAILABLE, AND BASED ON INVESTIGATION RESULTS OF A PREVIOUS SIMILAR COMPLAINTS DATABASE ANALYSIS, A MECHANICAL DAMAGE TO THE OUTLET PORT OF THE OXYGENATOR WAS EXCLUDED AS CAUSE OF THE EVENT SINCE IT WOULD HAVE DETERMINED A LEAKAGE DURING PRIMING PHASE WHICH WAS SUCCESSFULLY COMPLETED INDEED. THEREFORE, IT CANNOT BE RULED OUT THAT A WEAKENING OF THE ARTERIAL LINE CONNECTION ASSEMBLED ON THE OXYGENATOR PORT BY CUSTOMER OVER TIME DURING PROCEDURE MAY HAVE LED TO THE REPORTED FAILURE. THE BLOOD FLOW RATE HIGHER THAN PRIMING FLOW RATE TOGETHER WITH LOOSE OR ABSENT TIE WRAPS SECURING THIS CONNECTION WERE ALSO IDENTIFIED AS POTENTIAL CONTRIBUTING FACTORS. H3 OTHER TEXT : PART WAS NOT RETURNED FOR TESTING NOR VISUAL EVIDENCE OF THE ISSUE WAS PROVIDED.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT BLOOD LEAKAGE FROM INSPIRE OXYGENATOR WAS FOUND DURING THE PROCEDURE. THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA LEARNED THAT BLOOD POURED OUT OF ARTERIAL OUTLET CONNECTOR. THE EVENT OCCURRED DURING AORTIC CROSS CLAMP APPLICATION. MEDICAL TEAM ELECTED TO REPLACE LEAKING DEVICE WITH A NEW ONE AND THE CHANGE OUT OF THE OXYGENATOR WAS PERFORMED IN ABOUT TEN (10) MINUTES. NO NEGATIVE CONSEQUENCES TO THE PATIENT WERE COMMUNICATED. PART IS NOT AVAILABLE FOR RETURN NOR VISUAL EVIDENCE OF THE ISSUE WAS TAKEN BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414952 INSPIRE 6 STERILE INSPIRE OXYGENATORS DTZ SORIN GROUP ITALIA SRL. 2305180120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown