BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSPIRE 6

    MDR report key: 19740249 · Received July 15, 2024

    Report

    Report Number
    9680841-2024-00021
    Event Type
    Death
    Date Received
    July 15, 2024
    Date of Event
    June 20, 2024
    Report Date
    September 9, 2024
    Manufacturer
    SORIN GROUP ITALIA SRL.
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 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.11. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6 OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6) CHINA. THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA LEARNED THAT THE MEDICAL TEAM DID NOT ESTABLISH A DIRECT RELATIONSHIP BETWEEN THE MALFUNCTION OF THE PRODUCT AND THE DEATH OF THE PATIENT. IN PARTICULAR, THE FOLLOWING FINDINGS AROSE: - THE CAUSE OF THE DEATH IS CURRENTLY UNKNOWN SINCE THE AUTOPSY HAS NOT BEEN PERFORMED YET. - THE BLOOD LEAK WAS NOT QUANTIFIED (A DROP-BY-DROP LEAK RATE WAS CONFIRMED). - NO CHANGE-OUT OF THE DEVICE WAS PERFORMED AND NO ADDITIONAL MEDICAL INTERVENTION WAS UNDERTAKEN. - THE CONNECTION OF THE PURGE LINE WAS FOUND TIGHT AND SEAL DURING PRIMING WITHOUT ANY FLUID LEAK EXPERIENCED. ACCORDING TO A MEDICAL ASSESSMENT MEETING HELD BY LIVANOVA WITH A CLINICAL EXPERT, IT WAS HIGHLIGHTED THAT THE LEAKAGE FROM THE PURGE LINE DETERMINES A NEGLIGIBLE BLOOD LOSS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY TO THE PATIENT. IN ADDITION, GIVEN THE POSITIVE PRESSURE OF THE BLOOD COMPARTMENT, ANY LEAKAGE INVOLVES A PASSAGE OF FLUID/BLOOD FROM THE INSIDE TO THE OUTSIDE WITHOUT ANY RISK OF PATIENT CONTAMINATION/INFECTION. THEREFORE, IT WAS CONCLUDED THAT THE DEATH OF THE PATIENT WAS RELATED TO THE PRE-EXISTING PATIENT CONDITIONS, AND NOT DIRECTLY LINKED WITH THE MINIMAL BLOOD LOSS ENTITY FROM THE PURGE LINE CONNECTION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE LIVANOVA COMPLAINTS DATABASE REVEALED THAT THE BATCH CONCERNED OF PRODUCT WAS NOT INVOLVED IN ANY OTHER SIMILAR OCCURRENCES, NOR ANY ADVERSE TREND RELATING TO THE OBSERVED FAILURE MODE WAS IDENTIFIED BY THE LIVANOVA POST-MARKET SURVEILLANCE DATA ANALYSIS. THE NOTICED DEVICE WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. PART WAS DISCARDED BUT A PICTURE AS EVIDENCE OF THE DEFECT WAS PROVIDED, SHOWING TRACES OF BLOOD ON THE OUTSIDE OF THE OXYGENATOR PORT AND ABOVE THE MALE THREADED FITTING CONNECTOR OF THE LINE. PATIENT PASSED AWAY THE SAME DATE OF THE PROCEDURE (20TH JUNE) AND HAD SERIOUS HEALTH CONDITIONS BEFORE THE SURGERY (NOT CLARIFIED). THE CAUSE OF THE DEATH REMAINS UNKNOWN SINCE THE AUTOPSY ON THE PATIENT WAS NOT PERFORMED. THE BLOOD LOSS OCCURRED APPROXIMATELY 30 MINUTES AFTER THE BEGINNING OF THE CASE AND WAS NOT QUANTIFIED (A DROP BY DROP LEAK RATE WAS CONFIRMED). AS TROUBLESHOOTING, NO CHANGE-OUT OF THE DEVICE WAS PERFORMED AND NO ADDITIONAL MEDICAL INTERVENTION WAS UNDERTAKEN. NO ANOMALY WAS DETECTED DURING THE PRIMING PHASE THAT WAS SUCCESSFULLY COMPLETED, CONSEQUENTLY A MECHANICAL DAMAGE TO THE OXYGENATOR PORT AND/OR TO THE MALE LUER CONNECTOR WAS EXCLUDED. A MEDICAL ASSESSMENT MEETING CONCLUDED THAT THE DEATH OF THE PATIENT WAS RELATED TO THE PRE-EXISTING CONDITIONS OF THE PATIENT, AND NOT DIRECTLY LINKED WITH THE MINIMAL BLOOD LOSS ENTITY FROM THE PURGE LINE CONNECTION. BASED ON ALL THE ABOVE ELEMENTS, IT CANNOT BE RULED OUT THAT THE MOST LIKELY ROOT CAUSE OF THE COMPLAINED EVENT WAS A LOOSE CONNECTION OF THE PURGE LINE WITH THE OXYGENATOR PORT, REASONABLY CONSISTING IN A POORLY TIGHTENED TERMINAL END BY THE USER THAT RESULTED INTO A LEAKAGE DURING THE SURGERY UNIQUELY AND NOT DURING PRIMING DUE TO THE DIFFERENT PRESSURE LEVELS INVOLVED. THIS LINE IS PRE-ASSEMBLED ON THE OXYGENATOR AT LIVANOVA FACILITY, BUT A PARTIAL LOSS OF SEAL MAY OCCUR FOLLOWING THERMAL OR MECHANICAL STRESSES ACCIDENTALLY APPLIED AFTER THE RELEASE OF THE PRODUCT; IN THIS REGARD, IFU'S OF THE INSPIRE OXYGENATOR RECOMMEND TO VERIFY ALL CONNECTIONS AND SECURE THEM PRIOR TO STARTING THE PROCEDURE.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT STATING THAT A BLOOD LOSS FROM INSPIRE PURGE LINE OCCURRED APPROXIMATELY 30 MINUTES AFTER THE BEGINNING OF THE CASE. PATIENT PASSED AWAY THE SAME DATE OF THE PROCEDURE (B)(6) 2024 AND HAD SERIOUS HEALTH CONDITIONS BEFORE THE SURGERY (NOT CLARIFIED).

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210101 INSPIRE 6 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL. 050713CN 2402200117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death