BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 10023447 · Received May 5, 2020

    Report

    Report Number
    9680841-2020-00008
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 3, 2020
    Report Date
    June 26, 2020
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10 THE VIDEO PROVIDED SHOWED THE PRESENCE OF LIQUID DROPS AT THE INSPIRE OXYGENATOR 8F INLET AND NOT AT THE OUTLET AS REPORTED BY THE CUSTOMER. THE COMPLAINED INSPIRE OXYGENATOR 8F WAS RETURNED TO LIVANOVA FACILITY FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED OXYGENATOR FOUND NO DAMAGED NOR ANY DEFECT. TWO TESTS HAVE BEEN EXECUTED TO INVESTIGATE THE CLAIMED LEAKAGE ACROSS THE BLOOD/WATER INTERFACE: BLOOD COMPARTMENT INTEGRITY TEST. WATER COMPARTMENT INTEGRITY TEST. THE OXYGENATOR WAS DRIED, ASSEMBLED INTO A CIRCUIT FILLED WITH METHYLENE BLUE AND BLOOD COMPARTMENT WAS PRESSURIZED WHILE MONITORING THE INTERNAL PRESSURE VALUES WITH THE HELP OF A PRESSURE GAUGE. TO SIMULATE OVERSTRESSING OPERATING CONDITIONS, THE OXYGENATOR WAS PRESSURIZED UP TO 1.5 TIMES THE MAXIMUM RECOMMENDED PRESSURE FOR BLOOD COMPARTMENT (AS PER PRODUCT IFU, REFER TO PARAGRAPH G. PRIMING AND RECIRCULATION PROCEDURE, POINT 6 - OXYGENATOR AND CIRCUIT PRIMING: ¿THE PRESSURE LEVEL INSIDE THE BLOOD COMPARTMENT OF THE INSPIRE 8F M OXYGENATOR MODULE SHALL NOT EXCEED 1 BAR.¿). TESTS RESULTED IN NO LEAKS FROM THE BLOOD COMPARTMENT THROUGH THE WATER COMPARTMENT. THE OXYGENATOR WAS EMPTIED, ASSEMBLED INTO A CIRCUIT FILLED WITH METHYLENE BLUE AND WATER COMPARTMENT WAS PRESSURIZED WHILE MONITORING THE INTERNAL PRESSURE VALUES WITH THE HELP OF A PRESSURE GAUGE. THE WATER COMPARTMENT WAS PRESSURIZED UP TO THE MAXIMUM INTERNAL PRESSURE VALUE RECOMMENDED IN PRODUCT IFU (AS PER PRODUCT IFU, REFER TO PARAGRAPH F. PREPARATION AND SET-UP, POINT 3 - HEATER-COOLER SET-UP: ¿THE WATER PRESSURE IN THE HEAT EXCHANGER MUST NOT EXCEED 2 BAR¿.). TESTS RESULTED IN NO LEAKS FROM THE WATER COMPARTMENT THROUGH THE BLOOD COMPARTMENT. THE DEVICE HISTORY RECORD (DHR) OF INVOLVED OXYGENATOR CONFIRMED THE OXYGENATOR WAS RELEASED CONFORMING TO PRODUCT SPECIFICATION. NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECORDED INTO LIVANOVA COMPLAINT DATABASE RELEVANT TO THE OXYGENATOR LOT THUS SUGGESTING THERE IS NO SYSTEMATIC ISSUE. LIVANOVA INVESTIGATION COULD NOT REPRODUCE THE REPORTED ISSUE: THE OXYGENATOR IS WORKING PER SPECIFICATION. AS THE ISSUE COULD NOT BE REPRODUCED, NO ROOT CAUSE COULD BE IDENTIFIED. HOWEVER, THE PRESENCE OF WATER DROPS AT THE OXYGENATOR INLET CONNECTOR IS COHERENT WITH CONDENSATION PHENOMENON RELATED TO THE POSSIBILITY OF WATER MOLECULES TO PASS THROUGH THE OXYGENATOR FIBERS DEPENDING ON TEMPERATURE DIFFERENCE BETWEEN AIR AND BLOOD COMPARTMENTS, IN PARTICULAR IN OPERATING ROOMS WHERE AIR TEMPERATURE IS OFTEN LOWER THAN 18 °C. TO REDUCE MOISTURE FORMATION INSIDE INSPIRE OXYGENATOR, PRODUCT IFU RECOMMEND STARTING TO FLOW THE GAS ONLY WHEN THE BYPASS BEGINS. THE PRESENCE OF WATER VAPOR CONDENSATION DOES NOT AFFECT PERFORMANCES AND/OR STERILITY OF INSPIRE AS ONCE THE BLOOD SIDE IS PRIMED, THE SMALL AMOUNT OF CONDENSED WATER IS ABSORBED INTO THE PRIME. AS FOR ALL THE ABOVE, NO CORRECTIVE ACTION WAS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN00211 FI TAMPERE PHISIO LOT 2001090073) 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 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 K180448. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED OXYGENATOR HAS BEEN RECEIVED AT SORIN GROUP (B)(4) FOR INVESTIGATION AND INVESTIGATION HAS NOT BEEN INITIATED YET. 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

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING THE SET-UP OF THE ECC, WATER WAS IDENTIFIED IN THE INSPIRE 8F ARTERIAL OUTLET OF OXYGENATOR WHILE WATER WAS RUNNING IN THE WATER COMPARTMENT OF THE OXYGENATOR HEAT EXCHANGER. THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487517 INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2001030099

    Patients

    Seq Age Sex Outcome Treatment
    1