BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 11459170 · Received March 11, 2021

    Report

    Report Number
    9680841-2021-00007
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 3, 2021
    Report Date
    April 27, 2021
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE OXYGENATOR WAS RETURNED TO MANUFACTURER FOR PRODUCT ANALYSIS: THE REPORTED EVENT WAS NOT REPRODUCED AND DEVICE WAS FOUND TO BE PROPERLY WORKING AS PER DESIGN SPECIFICATION WITH NO DEVIATION IDENTIFIED. ANALYSIS OF PROVIDED PUMP-SHEET COULD NOT BE PERFORMED SINCE NO ALL THE RELEVANT DATA WERE MADE AVAILABLE. NO FURTHER SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR NOTICED PRODUCT LOT. MANUFACTURING RECORDS HAVE BEEN VERIFIED TO BE CONFORMING TO SPECIFICATIONS. BASED ON HISTORICAL DATA ANALYSIS, THE HIGH TRANSMEMBRANE OXYGENATOR PRESSURE GRADIENT IS RELATED TO THE INCREASE OF HYDRAULIC RESISTANCE AS A RESULT OF UNDESIRED CELLULAR ACTIVATION ASSOCIATED WITH PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THIS TYPE OF EVENT IS A MULTI-FACTORIAL PHENOMENON POSSIBLY TRIGGERED BY A COMBINATION OF CLINICAL PROCEDURE, THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT-SPECIFIC HEALTH CONDITIONS. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN00816 DK AALBORG LOT 2011230106) 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 COMPLAINED INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER 050703) IS REGISTERED IN THE USA (510(K) NUMBER: K180448). 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 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT YET RETURNED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT STATING THAT, DURING A PROCEDURE, THE PRESSURE BEFORE THE INSPIRE 8F OXYGENATOR SLOWLY INCREASED. THE OXYGENATOR PERFORMS AS EXPECTED. THE PRESSURE CONTINUED TO RISE SLOWLY AND THE MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THE CIRCULATION IS INTERRUPTED FOR APPROXIMATELY 4 MINUTES THEN THE CIRCULATION WAS RE-ESTABLISHED, AND THE OPERATION WAS COMPLETED WITH NO ISSUE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364732 INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR DTZ SORIN GROUP ITALIA SRL 2011200156

    Patients

    Seq Age Sex Outcome Treatment
    1