BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

    MDR report key: 16823989 · Received April 27, 2023

    Report

    Report Number
    9680841-2023-00016
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    March 30, 2023
    Report Date
    July 24, 2023
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THE WAS NO PATIENT INVOLVEMENT. D.4. THE SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE INVOLVED SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K021830). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM WAS ASSEMBLED. H.10. SORIN GROUP ITALIA MANUFACTURES THE SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM. THE INCIDENT OCCURRED IN UNITED STATES. THE DEVICE HAS BEEN REQUESTED FOR INVESTIGATION. 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 RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NO VISUAL EVIDENCE SHOWING THE PHENOMENON WAS PROVIDED, CONSEQUENTLY UNIT WAS REQUESTED BACK FOR INVESTIGATION AT LIVANOVA FACILITY. RETURNED PART WAS VISUALLY INSPECTED AND NO DAMAGE NOR DEFORMATIONS WERE NOTICED ON THE UMBRELLA VALVE WHICH WAS FOUND TO BE CORRECTLY SEATED IN ITS HOUSING. A SUBSEQUENT FUNCTIONAL TEST WITH METHYLENE BLUE WAS PERFORMED TO EVALUATE POTENTIAL DE-PRIMING OF THE "UNIT AND" THE UNIT BEHAVED AS EXPECTED THUS REVEALING A PROPER FUNCTIONING OF THE UMBRELLA VALVE. VERIFICATION OF PRODUCTION RECORDS CONFIRMED THAT NOTICED LOT WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. ACCORDING TO THE COMPLAINTS DATABASE REVIEW, NO OTHER SIMILAR COMPLAINTS HAVE BEEN SUBMITTED FOR THE CLAIMED BATCH OUT OF 840 MANUFACTURED UNITS. BASED ON ALL THE ABOVE, IT CANNOT BE EXCLUDED THAT THE MOST LIKELY ROOT CAUSE OF COMPLAINED PHENOMENON WAS ASSIGNED TO ACCIDENTAL MISPLACEMENT OF THE UMBRELLA VALVE DURING SURGERY FOLLOWING HANDLING/MANIPULATION OF THE DEVICE. 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 PRIMING OF THE CARDIOPLEGIA KIT, THE SYSTEM WAS OPENED TO AIR VIA THE PATIENT LINE AND BCD VANGUARD HEAT EXCHANGER INTOOK AIR FROM THE HYDROPHOBIC VALVE AT THE TOP. MEDICAL TEAM ELECTED TO CHANGED THAT CARDIOPLEGIA KIT OUT WITH ANOTHER ONE THAT WORKED JUST FINE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614041 SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM HEAT EXCHANGER, CARDIOPLEGIA DTR SORIN GROUP ITALIA SRL 2212210043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown