BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 15426620 · Received September 15, 2022

    Report

    Report Number
    9680841-2022-00041
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 15, 2022
    Report Date
    November 16, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE 7F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN01579, LOT2203070114) 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. DEVICE AVAILABLE FOR EVALUATION: DEVICE HAS NOT BEEN SAVED FOR INVESTIGATION. THE COMPLAINED INSPIRE 7F 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 050729) IS REGISTERED IN THE USA (510(K) NUMBER: K200683). DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 7F 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. THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA LEARNED THAT - NO CHANGE-OUT OF THE OXYGENATOR WAS CARRIED OUT AND NO INJURY TO PATIENT OCCURRED. - WITHIN 10-15 MINUTES OF CPB THE PRE-MEMBRANE PRESSURE STARTED TO INCREASE WITHOUT A NOTABLE DECREASE IN POST-MEMBRANE PRESSURE. PT¿S MAP WAS NOT AFFECTED. THIS WAS CLOSELY MONITORED. - WITHIN 30 MINUTES OF CPB PRE-MEMBRANE PRESSURES STARTED TO EXCEED 425MMHG, FLOW TO PATIENT WAS DECREASED, MAP WAS MAINTAINED WITH PHENYLEPHRINE AND EVENTS DISCUSSED WITH ANESTHESIA. DECISION WAS MADE TO TREAT THE SITUATION AS A INCREASED TRANS-MEMBRANE PRESSURE EVENT. THEREFORE, THE SYSTEM TEMPERATURE WAS WARMED AND 8MG OF MGSO4 WAS ADMINISTERED WITH NO EFFECT. - MEDICAL TEAM ELECTED TO ADMINISTER DOUBLE DOSE OF EPOPROSTENOL AND PRE-MEMBRANE PRESSURES BEGAN TO DECREASE WITHIN 1 MINUTE WITH A CONTINUED THERAPEUTIC EFFECT OVER THE FOLLOWING 20 MINUTES. THIS REQUIRED MAP SUPPORT UTILIZING INCREASING DOSES OF PHENYLEPHRINE THAT THE PATIENT HAD NOT PREVIOUSLY REQUIRED AND WERE NOT AT DOSE LEVELS OUTSIDE OF A TYPICAL CARDIAC CASE. - THERE WAS A SLIGHT INCREASE IN PRE-MEMBRANE PRESSURES APPROXIMATELY 45 MINUTES POST ADMINISTRATION OF THE EPOPROSTENELOL BUT THAT HAD LITTLE CLINICAL IMPACT. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. - ACTS REMAINED OVER 600 SECONDS THROUGHOUT THE CASE. HGB REMAINED OVER 100 THROUGHOUT. GLUCOSE AND POTASSIUM CLIMBED AS PREDICTED. NO BLOOD WORK WAS UNCOMMON. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE COMPLAINED OXYGENATOR WAS NOT MADE AVAILABLE. THEREFORE, NO FUNCTIONAL TESTING COULD BE PERFORMED. VERIFICATION OF PRODUCTION RECORDS CONFIRMED THAT COMPLAINED BATCH OF INSPIRE OXYGENATOR WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. NO OTHER SIMILAR COMPLAINTS AFFECTING COMPLAINED BATCH OF OXYGENATOR WERE NOTIFIED. BASED ON AVAILABLE INFORMATION, LITERATURE REVIEW AND HISTORICAL DATA ANALYSIS, THE INCREASED HYDRAULIC RESISTANCE TO PASSAGE OF BLOOD FACED BY THE CUSTOMER IS ASSIGNED TO UNDESIRED CELLULAR ACTIVATION AND BUILD UP OF BIOLOGICAL MATERIAL INSIDE CIRCUIT AS A RESULT OF PLATELET ADHESION AND FIBRIN LAYER DEPOSITION IN OXYGENATOR FIBERS. HIGH PRESSURE EXCURSION EVENT ACROSS OXYGENATOR IS A MULTIFACTORIAL PHENOMENON POSSIBLY AFFECTED BY INTERACTION OF MULTIPLE CONTRIBUTING FACTORS SUCH AS CLINICAL PROCEDURE (E.G. SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT-SPECIFIC HEALTH CONDITIONS. THE RISK IS IN THE ACCEPTABLE REGION. NO DEVICE MALFUNCTION COULD BE CONFIRMED. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, INCREASE TRANS-MEMBRANE PRESSURE WAS OBSERVED DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603781 INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2203070114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown