BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 11692551 · Received April 20, 2021

    Report

    Report Number
    9680841-2021-00010
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 22, 2021
    Report Date
    August 3, 2021
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED REPORT OF HIGH-PRESSURE EXCURSION EVENT DEVELOPED ACROSS INSPIRE OXYGENATOR 8F DURING SURGERY. MEDICAL TEAM ELECTED TO CHANGE-OUT THE DEVICE (OPERATION LASTED MORE THAN 3 MINUTES) AND PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT IMPACT. MANUFACTURING RECORDS WERE VERIFIED, AND COMPLAINT HISTORY WAS REVIEWED: CLAIMED DEVICE WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS AND NO FURTHER SIMILAR ISSUES WERE EVER REPORTED FOR BATCH CONCERNED OUT OF 240 TOTAL MANUFACTURED UNITS SOLD WORLDWIDE, THIS EXCLUDING A SYSTEMATIC QUALITY PROBLEM LOT-RELATED. INVOLVED UNIT WAS RETURNED TO LIVANOVA FACILITY FOR INVESTIGATION AFTER DECONTAMINATION PROCESS. THE DEVICE WAS FOUND CLOGGED, WITH VISIBLE TRACES OF BLOOD INSIDE FIBER BUNDLE. TO REMOVE OBSERVED TRACES, BLOOD COMPARTMENT WAS GENTLY FLUSHED WITH DEMINERALIZED WATER AND DRIED WITH COMPRESSED AIR. DURING RINSING PHASE, THICK BLOOD WAS EJECTED FROM PURGE AND ARTERIAL OUTLET PORTS. UPON COMPLETION OF WASHING PHASE, FUNCTIONAL TEST WITH BOVINE BLOOD WAS CARRIED OUT. CLAIMED DEVICE WAS TESTED AS PER DESIGN SPECIFICATIONS: ACCORDING TO TEST RESULTS, RETURNED UNIT WAS FOUND TO BE PROPERLY WORKING WITHOUT ANY PERFORMANCE DEVIATION IDENTIFIED. THE MEASURED P VALUES WERE ALIGNED WITH THE ACCEPTABLE RANGE OF VALUES PRESCRIBED WITHIN PRODUCT SPECIFICATIONS AS PER REPORTED BLOOD PARAMETERS TEST CONDITIONS BASED ON INVESTIGATION RESULTS, ANY PRODUCT MALFUNCTION WAS EXCLUDED. THE NECESSARY CLEANING OF THE UNIT PRIOR TO FUNCTIONALLY TESTING THE DEVICE IN LIVANOVA LABORATORY MOST LIKELY REMOVED ANY CELLULAR DEPOSITION AND THUS RESTORED IT TO PRE-CLINICAL CONDITIONS. THE CLAIMED HIGH TRANSMEMBRANE OXYGENATOR PRESSURE GRADIENT, NOT REPRODUCED DURING LAB TESTING BUT CONFIRMED BY PUMP-SHEET ANALYSIS, WAS REASONABLY ASSIGNED TO THE INCREASE OF HYDRAULIC RESISTANCE AS A RESULT OF UNDESIRED CELLULAR ACTIVATION ASSOCIATED WITH PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATORS. THIS TYPE OF EVENT IS A MULTI-FACTORIAL PHENOMENON POSSIBLY TRIGGERED BY A COMBINATION OF CLINICAL PROCEDURE, THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT-SPECIFIC HEALTH CONDITIONS. THE RISK IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL MAINTAIN MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INTIAL REPORT

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN00983 DE BAD NEUSTADT) 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 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 ITALIA MANUFACTURES THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN BAD (B)(6). 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 OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE INLET PRESSURE INCREASE AFTER ABOUT 1H OVER 600MMHG; PUMP STOPS; DELTA P WAS 550MMHG, CUSTOMER CHANGE TO A OTHER HLM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591797 INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR DTZ SORIN GROUP ITALIA SRL 2102030001

    Patients

    Seq Age Sex Outcome Treatment
    1