BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    MDR report key: 8762626 · Received July 4, 2019

    Report

    Report Number
    9680841-2019-00026
    Event Type
    Malfunction
    Date Received
    July 4, 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6), ITALY. THE INVOLVED DEVICE HAS BEEN REQUESTED SEVERAL TIMES BUT NEVER RETURNED BY THE CUSTOMER. NIETHER VISUAL INSPECTION NOR FUNCTIONAL INVESTIGATION COULD BE PERFORMED. IN CASE THE COMPLAINED OXYGENATOR WILL BE RETURNED, LIVANOVA IS COMMITTED TO PROVIDE FOLLOW UP ADDITIONAL RESULT IF RELEVANT ADDITIONAL RESULTS WOULD ARISE FROM THE INVESTIGATION. THE DEVICE HISTORY RECORD REVIEW OF THE OXYGENATOR DID NOT HIGHLIGHT ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESS. THE CLAIMED LOT WAS RELEASED CONFORMING TO SPECIFICATIONS. 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 IS 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. LIVANOVA WILL KEEP MONITORING THE MARKET. DEVICE REQUESTED BUT NOT RETURNED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 8 START P OXYGENATOR (CATALOG NUMBER 050712, LOT 1904190015) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050712 IS SIMILAR TO THE INSPIRE 8 OXYGENATOR CATALOG NUMBER 050714, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. THE PRODUCT ITEM 050712 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 8 OXYGENATOR CATALOG NUMBER 050714, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130433). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO THE MANUFACTURER SORIN GROUP (B)(4) FOR INVESTIGATION BUT IT HAS NOT YET BEEN RECEIVED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATION OR NON-CONFORMITY RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) HAS BEEN INFORMED THAT, DURING A PROCEDURE, A INCREASED TRANS-MEMBRANE PRESSURE WAS OBSERVED. THE MEDICAL TEAM ELECTED TO ADMINISTER HEPARIN AND NA-NITROPRUSSIATE. THE PRESSURE DID NOT DECREASE AND THE TEAM ELECTED TO REPLACE THE INSPIRE OXYGENATOR. THE CHANGE-OUT LASTED MINUTES. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556457 INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 1904190015

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR