BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE HVR

    MDR report key: 15074147 · Received July 21, 2022

    Report

    Report Number
    9680841-2022-00030
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 22, 2022
    Report Date
    November 22, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INFORMATION HAS BEEN PROVIDED. THE INSPIRE HARD VENOUS RESERVOIR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA (ITEM 046006107, LOT 2206700087). THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE INVOLVED INSPIRE HARD VENOUS RESERVOIR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE RESERVOIR (CATALOG NUMBER 050704) IS ALSO 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. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE HARD VENOUS RESERVOIR. THE INCIDENT OCCURRED IN (B)(6), UNITED STATED OF AMERICA. THE INVOLVED DEVICE HAS NOT BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. DURING FOLLOW UP WITH THE CUSTOMER, LIVANOVA LEARNED THAT THE FILTER MEDIA/SCREEN INSIDE THE RESERVOIR HAS RESULTED IN POST CANNULATION RESERVOIR CHANGE OUTS WITH PATIENT BLOOD. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT REQUESTED.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT OF INCREASED BREAKTHROUGH TIME OF THE BLOOD ENTERING THE VENOUS RETURN FILTER SCREEN OF INSPIRE HVR DURING SURGERY AFTER PATIENT CANNULATION PHASE. MEDICAL TEAM ELECTED TO CHANGE-OUT THE UNIT. THERE WAS NO PATIENT IMPACT. REVIEW OF COMPLAINTS DATABASE REVEALED ONE FURTHER SIMILAR CASE NOTIFIED FOR BATCH CONCERNED OF INSPIRE HVR FROM THIS SAME CUSTOMER, OUT OF (B)(4) TOTAL MANUFACTURED UNITS. THROUGH FOLLOW-UP COMMUNICATION, NO FURTHER DETAILS WERE GIVEN RELEVANT TO CHANGE-OUT PROCEDURE, PATIENT CLINICAL HISTORY AND ANY ADDITIONAL MEDICAL INTERVENTION ADOPTED TO TACKLE THE BLOOD FILTRATION ISSUE. DHR ANALYSIS CONFIRMED NO DEVIATIONS OR NON-CONFORMITIES WERE IDENTIFIED DURING MANUFACTURING PROCESS OF INVOLVED UNIT. AS PER PROCEDURE, BOTH PLASMA AND COATING TREATMENTS ARE CONDUCTED ON 100% OF HVR VENOUS RETURN FILTER (COATING WITH PHOSPHORYLCHOLINE FOR HEMO-COMPATIBILITY OF THE SURFACES TO PREVENT ACTIVATION OF THE BLOOD IN CONTACT WITH THE SAME). A VISUAL CHECK IS PERFORMED AT THE END OF ABOVE STEPS TO VERIFY THE ABSENCE OF WET AREAS, DEPOSITS, OPACITY AND OTHER DEFECTS. FINALLY, THE EMPTY HVR WITH NO FILTER PRE-ASSEMBLED UNDERGOES COATING TREATMENT TOO. BASED ON COLLECTED EVIDENCE, THE MOST LIKELY ROOT CAUSE OF COMPLAINED EVENT HAS BEEN ASSIGNED TO UNEXPECTED BLOOD ACTIVATION IN THE SYSTEM, RESULTING IN PARTIAL OCCLUSION OF FILTERING ELEMENTS AND CONCOMITANT REDUCTION OF OPEN SURFACE FOR BLOOD FLOW. THE BLOOD CLOTTING ISSUE IS A MULTI-FACTORIAL PHENOMENON CORRELATED WITH CLINICAL PROCEDURE THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. THE RISK IS IN THE ACCEPTABLE REGION. 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, DURING A PROCEDURE, CUSTOMER COMPLAINED OF INSUFFICIENT BREAKTHROUGH OF THE INSPIRE HARD VENOUS RESERVOIR. POST PRIMING DURING PRE-BYPASS RE-CIRCULATION THE SCREEN/FILTER MEDIA WAS OBSERVED TO HAVE HOLD UP OF AN ESTIMATED 400ML. 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
    2199710 INSPIRE HVR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2110290097

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown