BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 10942359 · Received December 3, 2020

    Report

    Report Number
    9680841-2020-00017
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 5, 2020
    Report Date
    March 10, 2021
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED REPORT THAT, DURING PROCEDURE USING INSPIRE 8F WITH FIO2=100%, ARTERIAL BLOOD WAS NOTED TO BE DARK AND LAB RESULTS CONFIRMED LOW PO2 VALUES. TO SOLVE THE PROBLEM, OXYGENATOR CHANGE OUT WAS PERFORMED; NO PATIENT OUTCOME WAS REPORTED. BASED ON THE AVAILABLE PUMP SHEET, BY KEEPING THE FIO2 AT 100%, HEMOGLOBIN OXYGEN SATURATION (SO2) WAS AROUND 80% AND THE PO2 VALUE LOWERED FROM 191 MMHG (PRE CPB) TO 48 MMHG, CONFIRMING THE EVENT. ACCORDING TO WHAT RECOMMENDED BY IFU, MEDICAL TEAM TACKLED AND SOLVED THE ISSUE BY REPLACING THE DEVICE: PERFUSION WAS INTERRUPTED FOR APPROXIMATELY ONE MINUTE. DHR VERIFICATION DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY LINKED WITH THE CLAIMED DEFECT. THE NOTICED LOT WAS NOT INVOLVED IN OTHER SIMILAR COMPLAINTS. MANY DIFFERENT FAILURE MECHANISMS CAN BE ASSUMED TO CAUSE THE COMPLAINED DEFECT. A POSSIBLE HYPOTHESIS IS THAT THE ISSUE IS MULTI-FACTORIAL, WHERE A COMBINATION OF TRIGGERING FACTORS MIGHT BE ORIGINATING THE PHENOMENON, INCLUDING INTERACTION WITH CLINICAL PROCEDURE AND PATIENT CONDITIONS. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA MAINTAINS AND DOCUMENT PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT.

    Additional Manufacturer Narrative · 0

    THE INVOLVED INSPIRE OXYGENATOR 8F HAS BEEN RETURNED TO LIVANOVA FACILITY FOR INVESTIGATION. DEVICE WAS DECONTAMINATED AS PER LIVANOVA PROCEDURE ON BLOOD CONTAMINATED GOODS. NO VISIBLE TRACES OF BLOOD INSIDE FIBER BUNDLE HAVE BEEN OBSERVED; SOME RESIDUES WERE PRESENT IN THE FILTER. BASED ON INVESTIGATION DATA, THE CLAIMED DEVICE WAS FOUND TO BE PROPERLY WORKING WITH NO DEVIATION IDENTIFIED RELATING TO BLOOD OXYGENATION CAPABILITY. IN DETAILS, PO2 VALUES WERE FOUND TO BE WITHIN SPECIFICATIONS. IN ADDITION, AS SHOWN IN THE PICTURE OF THE INVESTIGATION, WATER CONDENSATION PHENOMENON INSIDE MICROPOROUS FIBERS WAS ALSO OBSERVED; IT IS REASONABLE TO CORRELATE THIS UNEXPECTED BEHAVIOR OF THE OXYGENATOR WITH FIBERS HYDROPHILIZATION MOST LIKELY ASSOCIATED WITH HIGH-HUMIDITY STORAGE CONDITIONS. BASED ON ALL GATHERED FACTS, NO DIRECT RELATIONSHIP BETWEEN COMPLAINED EVENT AND ANY POSSIBLE DEVICE-RELATED QUALITY PROBLEM WAS CONFIRMED. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION HAS BEEN PROVIDED. THE INSPIRE 8F M OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS PENDING. THE INVOLVED INSPIRE 8F M OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER 050703) IS ALSO 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 OXYGENATOR. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION AND NOT YET RECEIVED. 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 RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, AT THE BEGIN OF A PROCEDURE, THE PATIENT BLOOD OXYGENATION WAS LOW. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. 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
    1407853 INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2007270093

    Patients

    Seq Age Sex Outcome Treatment
    1