BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER AND PHISIO

    MDR report key: 8374196 · Received February 27, 2019

    Report

    Report Number
    9680841-2019-00007
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    January 23, 2019
    Report Date
    May 29, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1810220202) 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. (B)(4). 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 STAND ALONE OXYGENATOR (CATALOG NUMBER 050703) IS REGISTERED IN THE USA (510(K) NUMBER: K130433). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. PER EXEMPTION NUMBER E2016005. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RETURNED.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN TREVISO, ITALY. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE INVOLVED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND SUBMITTED TO GAMMA RAY DECONTAMINATION PRIOR THE INSPECTION. THE VISUAL INSPECTION FOUND NOR DEFECTS NEITHER EVIDENT NON-CONFORMITIES. THE DEVICE WAS SUBMITTED TO TESTING FOR VERIFICATION OF TRANSMEMBRANE PRESSURE DROP. THE TEST RESULTS REPRODUCED THE CLAIMED ISSUE, THE PRESSURE DROP VALUES MEASURED DURING OUR LABORATORY TEST WERE ABOVE DEVICE SPECIFICATIONS. BASED ON THE EVIDENCE OF DEVICE INSPECTION AND ON PREVIOUS INVESTIGATED SIMILAR CASES, IT CAN BE CONFIRMED THAT THE INCREASE OF PRESSURE DROP HAS BEEN ASSOCIATED WITH PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THE MOST PROBABLE ROOT CAUSE OF PLATELET ADHESION AND FIBRIN DEPOSITION IS MULTI-FACTORIAL AND INCLUDE CLINICAL PROCEDURE (E.G SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. BASED ON MEDICAL LITERATURE, THE ORIGIN OF THE ACTIVATION AND INTERACTION APPEAR TO BE MULTI-FACTORIAL IN NATURE AND NOT DEVICE SPECIFIC. FOR THIS REASON, NO SPECIFIC CORRECTIVE ACTION HAS BEEN IDENTIFIED AT THE PRESENT DATE. SORIN GROUP ITALIA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    ON (B)(6) 2019, SORIN GROUP (B)(4) HAS RECEIVED A REPORT OF INCREASED TRANSMEMBRANE OXYGENATOR PRESSURE DURING A PROCEDURE RELATED TO AN OXYGENATOR INSPIRE 8F. DURING FOLLOW UP INFORMATION WITH THE CUSTOMER, ON (B)(6) 2019, SORIN GROUP (B)(4) HAS BEEN INFORMED THAT, AS A CONSEQUENCE OF THE INCREASED THE TRANSMEMBRANE OXYGENATOR PRESSURE, THE MEDICAL PROCEDURE STRATEGY WAS MODIFIED TO AVOID OXYGENATOR CHANGE-OUT OR RISK FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. SORIN GROUP (B)(4) HAS NOT BEEN INFORMED OF ANY PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167699 INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER AND PHISIO OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 1810240143

    Patients

    Seq Age Sex Outcome Treatment
    1