BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    MDR report key: 8763965 · Received July 5, 2019

    Report

    Report Number
    9680841-2019-00028
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 5, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6 M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN UNITED "KINGDOM". THE COMPLAINED OXYGENATOR WAS RETURNED FILLED WITH FORMALDEHYDE. TO SUBMIT THE DEVICE TO TEST FOR TRANSMEMBRANE PRESSURE VERIFICATION, THE DEVICE WAS EXTENSIVELY RINSED. HOWEVER, IT WAS NOT POSSIBLE TO REMOVE MOST OF BIOLOGICAL TRACES: NO IN-FLOW PASSAGE OF FLUID WAS ALLOWED, THUS PREVENTING THE RINSING OF THE DEVICE. AS PER THE CONDITIONS OF RETURNED DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED. THE PATIENT HAD A JAK2 PATHOGENIC VARIANT WHICH IS CONSISTENT WITH MYELOPROLIFERATIVE DISEASE, RESULTING IN INCREASED NUMBERS OF RED CELLS AND PLATELETS WITH INCREASED THROMBOSIS AND PLATELET AGGREGATION. AS PER THE EVIDENCES COLLECTED, THE ROOT CAUSE OF THE EVENT COULD NOT BE TRACED TO ANY DEVICE-RELATED MALFUNCTION SINCE THE INCREASE OF HYDRAULIC RESISTANCE EXPERIENCED BY CUSTOMER WAS RELATED TO UNDESIRED CELLULAR ACTIVATION ASSOCIATED WITH PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. BASED ON MEDICAL LITERATURE, THE ORIGIN OF THE ACTIVATION AND INTERACTION APPEARS TO BE NOT DEVICE RELATED AND TO BE MULTI-FACTORIAL. FOR THIS REASON, NO SPECIFIC CORRECTIVE ACTION HAS BEEN IDENTIFIED AT THE PRESENT DATE. EVEN IF THE ORIGIN OF THE EVENT IS NOT DEVICE SPECIFIC AND NO DEVICE MALFUNCTION HAS EVER BEEN IDENTIFIED, THE MANUFACTURER IS SERIOUSLY ENGAGED IN THE MITIGATION OF ANY RESIDUAL RISKS. FOR THIS REASON, SORIN GROUP ITALIA HAD CONDUCTED A MULTIDISCIPLINARY INVESTIGATION TO BETTER UNDERSTAND THE FACTORS THAT PLAY A ROLE IN THE INCREASE OF THE TRANSMEMBRANE PRESSURE. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WERE NOT PROVIDED. PATIENT INFORMATION WERE NOT PROVIDED. PATIENT INFORMATION WERE NOT PROVIDED. THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (CATALOG IN00980, LOT 1903060058) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. THE COMPLAINED INSPIRE 6F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050702) IS REGISTERED IN THE USA (510(K) NUMBER: K130209). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(4). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN RECEIVED AT SORIN GROUP (B)(4) FACILITIES FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON DATE (B)(6) 2019, LIVANOVA HAS BEEN INFORMED THAT, DURING A PROCEDURE, A INCREASED TRANS-MEMBRANE PRESSURE WAS OBSERVED. THE MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. ON DATE (B)(6) 2019, DURING A VISIT, LIVANOVA HAS BEEN INFORMED THE PATIENT DEATH OCCURRED ON (B)(6) 2019 BUT WAS NOT RELATED TO THE DEVICE. IN DETAILS, PERFUSIONIST SUSPECT PATIENT COAGULOPATHY WAS AT THE ROOT CAUSE OF THE PATIENT DEMISE. ON THE SAME DATE, LIVANOVA HAS BEEN INFORMED THAT METARAMINOL AND NORADRENALINE WERE ADMINISTERED TO THE PATIENT DURING THE PROCEDURE. ON DATE (B)(6) 2019, LIVANOVA HAS BEEN INFORMED THE OXYGENATOR CHANGE OUT LASTED 1 MINUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559085 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR DTZ SORIN GROUP ITALIA SRL 03704

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR