BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8965439 · Received September 5, 2019

    Report

    Report Number
    9680841-2019-00032
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 6, 2019
    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

    COMPLAINED INSPIRE 8 OXYGENATOR WAS RETURNED SORIN ITALIA FOR INVESTIGATION AND SUBJECTED TO DECONTAMINATION AS PER LIVANOVA PROCEDURE ON BLOOD CONTAMINATED GOODS. SIMULATED USE TEST PERFORMED ACCORDING TO RELEVANT STANDARD CONFIRMED THE OXYGENATOR PERFORMANCE WERE IN LINE WITH PRODUCT SPECIFICATIONS: DURING LIVANOVA LABORATORY TEST THE DEVICE BEHAVED AS EXPECTED. DHR VERIFICATION DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY RELATED TO THE CLAIMED ISSUE. THE COMPLAINED LOT WAS NOT INVOLVED IN ANY OTHER SIMILAR EVENT. AS PER THE EVIDENCES COLLECTED, THE ROOT CAUSE OF THE EVENT COULD NOT BE TRACED TO ANY DEVICE-RELATED MALFUNCTION. LIVANOVA BELIEVES A POSSIBLE ROOT CAUSE OF THE ISSUE EXPERIENCED BY THE CUSTOMER IS MULTI-FACTORIAL, WHERE A COMBINATION OF TRIGGERING FACTORS MIGHT BE ORIGINATING THE PHENOMENA, INCLUDING INTERACTION WITH CLINICAL PROCEDURE AND PATIENT. AS THE OCCURRENCE OF SUCH KIND OF EVENT IS VERY LOW AND A CLEAR ROOT CAUSE COULD NOT BE ASSESSED, NO CORRECTIVE ACTION WILL BE UNDERTAKEN. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WERE NOT PROVIDED. THE INSPIRE 8 M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (CATALOG IN00817, LOT 1906250181) 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 8 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 050701) IS REGISTERED IN THE USA (510(K) NUMBER: K130433). 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 8 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. THE INVOLVED DEVICE HAS BEEN REQUESTED BUT NOT RECEIVED AT SORIN GROUP (B)(4) FACILITIES. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, GAS ANALYSIS OF BLOOD SAMPLE SHOWED LOW PO2 LEVELS DESPITE CONTINUOUS BLOOD PARAMETER MONITOR SHOWED ADEQUATE PO2 VALUES. THE MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THE CHANGE-OUT OCCURRED WITHOUT INTERRUPTING THE CEC. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761732 INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 1906240092

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR