BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD

    MDR report key: 16672299 · Received April 4, 2023

    Report

    Report Number
    9680841-2023-00008
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    February 28, 2023
    Report Date
    July 24, 2023
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WERE NOT PROVIDED. D.4. THE COMPLAINED BCD VANGUARD IS A NON STERILE COMPONENT SOLD TO AN ASSEMBLER IN JAPAN. THE EXPIRATION DATE OF THE STERILE COMPONENEN IS UNKNOWN. THE COMPLAINED BCD VANGUARD (CATALOG NUMBER 050228J) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. G.5. THE PRODUCT ITEM 050228J IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE BCD VANGUARD ITEM 050228, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: (B)(6)). H.4. THE COMPLAINED BCD VANGUARD IS A NON STERILE COMPONENT SOLD TO AN ASSEMBLER IN JAPAN. THE MANUFACTURING DATE OF THE STERILE DEVICE IS UNKNOWN. H.10. SORIN GROUP ITALIA MANUFACTURES THE BCD VANGUARD. THE INCIDENT OCCURRED IN JAPAN. 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. INVOLVED PART WAS VISUALLY INSPECTED AND NO DAMAGE TO UMBRELLA VALVE WAS NOTICED. VALVE 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. THE TEST CONFIRMED AIR INTAKE IN THE UPPER PART OF THE DEVICE. DEEP DIVE INSPECTION OF THE LEAKING AREA AT ADVANCED SYSTEM VIEWER SHOWED THE PRESENCE OF A CRACK/FISSURE AS CAUSE OF THE FLUID LOSS. LABORATORY TESTING IN MIRANDOLA DID NOT CONFIRM ANY FUNCTIONAL FAILURE OF THE UMBRELLA VALVE WHICH WAS FOUND INTACT AND PERFECTLY SEATED IN ITS HOUSING. VERIFICATION OF PRODUCTION RECORDS CONFIRMED THAT NOTICED LOT WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. REVIEW OF COMPLAINTS DATABASE POINTED OUT NO FURTHER SIMILAR CASES NOTIFIED FOR BATCH CONCERNED FROM THE MARKET. BASED ON ALL THE ABOVE, THE MOST LIKELY ROOT CAUSE OF CLAIMED PHENOMENON SHALL BE ASSIGNED TO ACCIDENTAL MISPLACEMENT OF THE UMBRELLA VALVE DURING SURGERY FOLLOWING HANDLING/MANIPULATION OF THE DEVICE. FINALLY, INVESTIGATION RESULTS FROM LIVANOVA WERE ALIGNED WITH FINDINGS AT DISTRIBUTOR. THEREFORE IT CAN BE CONCLUDED THAT UNIT GOT ACCIDENTALLY CRACKED DURING PRODUCT DELIVERY FROM CUSTOMER FACILITY TO DISTRIBUTOR. 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, WHEN THE SECOND DELIVERY OF MYOCARDIAL PROTECTION STARTED (CARDIPLEGIC SOLUTION), THE AIR BUBBLE SENSOR SOUNDED AND AIR WAS FOUND OUT. AFTER RECIRCULATION TO REMOVE AIR BUBBLES, THE SECOND MYOCARDIAL PROTECTION WAS PERFORMED, AND THE PUMP WAS SUCCESSFULLY DISCONNECTED. THERE IS NO REPORT OF ANY PATIENT INJURY. WHEN UNIT WAS TESTED AT THE DISTRIBUTOR SITE, THE AIR INTAKE ISSUE WAS REPRODUCED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060619 VANGUARD RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA SRL 2106280144

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown