BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 13720953 · Received March 10, 2022

    Report

    Report Number
    9680841-2022-00015
    Event Type
    Injury
    Date Received
    March 10, 2022
    Date of Event
    February 9, 2022
    Report Date
    April 19, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED THE INSPIRE 8F OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN01586, LOT 2106250163) 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 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 8M 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. ACCORDING TO THE CUSTOMER, THEORETICAL FLOW RATE ON THE REMOTE ROLLER PUMP WAS 4L. FLOW RATE MEASURED WITH THEIR SCPC CENTRIFUGAL FLOW SENSOR WAS 3 L/M. MEDICAL TEAM FEAR THE USE OF 8F ON LARGE PATIENTS OR DISSECTIONS. DURING FOLLOW UP WITH THE CUSTOMER IT WAS CONFIRMED THAT: - THE CLAIMED OXYGENATOR IS NO LONGER AVAILABLE AND - THE PURGES LINES OF THE INSPIRE OXYGENATOR WERE OPEN AT THE TIME OF DETECTING THE DIFFERENT FLOW VALUES. IT SHALL BE NOTICED THAT, IN THE IFU OF THE INSPIRE 8F OXYGENATOR, IT IS INDICATED IF THE PURGE LINES ARE KEPT OPEN WHEN THE MAIN PUMP IS RUNNING, THIS WILL GENERATE SPONTANEOUS FLOW IN THE PURGE LINES (PARAGRAPH J. INITIATING BYPASS ¿ CHAPTER 5- CONTINUOUS AIR PURGE - SPONTANEOUS FLOW OF PURGE/RECIRCULATION LINE @ 150 MMHG ARTERIAL LINE PRESSURE AND 6 L/MIN MAIN PUMP BLOOD FLOW, IS APPROX. 620 ML/MIN WITH BOTH PURGE LINES OPEN, 420 ML/MIN WITH PRE FILTER PURGE LINE OPEN AND 420 ML/MIN WITH POST FILTER PURGE LINE OPEN.) IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    A SIMULATED USE TESTING WITH BLOOD HAS BEEN PERFORMED USING AN INSPIRE 8F OXYGENATOR PULLED FROM THE STOCK. BLOOD FLOW WAS MEASURED THREE SYSTEMS: (1) BY THE BLOOD FLOW SENSOR OF A SCPC PUMP (AT THE OXYGENATOR OUTLET), (2) BY MAIN ROLLER PUMP AND (3) BY A CONTROL FLOW SENSOR AT THE OXYGENATOR INLET. THE TEST WAS PERFORMED AT 6 LPM AND AT 4 LPM (THE LATTER TO REPRODUCE CUSTOMER CONDITIONS). WHEN THE SAMPLING AND PURGE LINES WERE KEPT CLOSED, AT BOTH FLOWS, THERE WAS NO DISCREPANCY BETWEEN THE VALUES MEASURED BY THE THREE SYSTEMS. WHEN THE SAMPLING AND PURGE LINES WERE KEPT OPEN, THE VALUES OF THE MAIN ROLLER PUMP AND THE CONTROL SENSOR (AT THE OXYGENATOR INLET) WERE ALIGNED. HOWEVER, THE BLOOD FLOW MEASURED BY THE BLOOD FLOW SENSOR OF A SCPC PUMP (AT THE OXYGENATOR OUTLET) WAS FOUND TO BE NEARLY 10% LOWER THAN THE OTHERS. THE SAME RESULTS WERE OBTAINED WHEN TEST WAS PERFORMED AT 4 LPM BLOOD FLOW RATE. IFU OF THE INSPIRE 8F OXYGENATOR INDICATES THAT A SPONTANEOUS FLOW IN THE PURGE LINES IS GENERATED IF THEY ARE KEPT OPEN WHEN THE MAIN PUMP IS RUNNING (PARAGRAPH J. INITIATING BYPASS ¿ CHAPTER 5- CONTINUOUS AIR PURGE). THEREFORE, THE ISSUE EXPERIENCED BY THE CUSTOMER IS CONFIRMED AND WAS DESCRIBED ALSO IN THE INSPIRE IFU. THEREFORE, NO DEVICE MALFUNCTION COULD BE CONFIRMED AS THE DEVICE BEHAVED AS EXPECTED. BASED ON THE ABOVE, NO CONTRIBUTION OF THE OXYGENATOR TO THE CLINICAL OBSERVATION OF HEMATURIA IN PATIENT URINE WAS ESTABLISHED. THE PATIENT BLOOD HEMOLYSIS COULD POTENTIALLY BE RELATED TO INCREASED PUMP FLOW RATE SET BY MEDICAL TEAM AFTER DETECTING DIFFERENCES BETWEEN CALCULATED AND MEASURED BLOOD FLOWS. SINCE NOT DEVICE MALFUNCTION COULD BE CONFIRMED AND THIS WAS AN ISOLATED EVENT, NO CORRECTIVE ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET. H3 OTHER TEXT: NOT RETURNED.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, ACCORDING TO THE PERFUSIONIST, WHEN USING AN INSPIRE 8F OXYGENATOR, THE BLOOD FLOW VALUE DETECTED BY THE SENSOR OF A SCPC PUMP IS LOWER THAN THE ONE CALCULATED BY THE ARTERIAL PUMP. THE DISCREPANCY IS OF 1.5 L/M. THE PERFUSIONIST ELECTED TO INCREASE THE PUMP FLOW TO OBTAIN A BLOOD FLOW OF 4L/M. THE TEAM INFORMED LIVANOVA THAT THEY HAVE NOTICED HEMATURIA IN THE PATIENT URINE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118177 INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2106290087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown