BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCD VANGUARD N/S

    MDR report key: 18510420 · Received January 15, 2024

    Report

    Report Number
    9680841-2024-00003
    Event Type
    Malfunction
    Date Received
    January 15, 2024
    Date of Event
    November 11, 2023
    Report Date
    April 23, 2024
    Manufacturer
    SORIN GROUP ITALIA
    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: K934847). 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. THE CARDIOPLEGIA HEAT EXCHANGER WAS ASSEMBLED BY A JAPANESE STERILE CIRCUIT ASSEMBLER AND WAS TESTED BY THE ASSEMBLER. THEIR TEST CONFIRMED AIR INTAKE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H10: REVIEW OF COMPLAINTS DATABASE POINTED OUT NO FURTHER SIMILAR CASES NOTIFIED FOR BATCH CONCERNED FROM THE MARKET. THE UNIT WAS REQUESTED BACK FOR INVESTIGATION AT LIVANOVA FACILITY. INVOLVED PART WAS VISUALLY INSPECTED AND NO EVIDENT DAMAGE NOR MISPLACEMENT OF UMBRELLA VALVE WAS NOTICED. A SUBSEQUENT FUNCTIONAL TEST WITH METHYLENE BLUE WAS PERFORMED TO EVALUATE POTENTIAL DE-PRIMING OF THE UNIT. IT IS EXPECTED THAT IF THE UMBRELLA VALVE IS CORRECTLY WORKING, THE DEVICE REMAINS FULL OF FLUID EVEN AFTER OPENING THE TUBING AT THE INLET. ON THE OTHER HAND, IF THE UMBRELLA IS NOT CORRECTLY WORKING, AIR INTAKE WILL OCCUR AS SOON AS THE INLET IS OPENED. ONCE THE INLET LINE WAS OPENED, THE LEVEL OF FLUID INSIDE THE DEVICE GRADUALLY LOWERED DUE TO DROP BY DROP FLUID LOSS FROM THE INLET LINE. VALVE WAS SLIGHTLY MANIPULATED AND RE-SEATED BUT THE EMPTYING OF THE UNIT DID NOT STOP. EMPTYING OF THE DEVICE WAS REPRODUCED DURING DE-PRIMING TEST, THEREFORE IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF REPORTED EVENT WAS A DEFECTIVE UMBRELLA VALVE. NO CONCERNING TREND FOR REPORTED FAILURE HAS BEEN POINTED OUT FROM POST MARKET ANALYSIS, THEREFORE NO SPECIFIC ACTION IS CURRENTLY DEEMED NECESSARY.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, AFTER PRIMING WAS COMPLETED AND THE UNIT WAS CONNECTED TO THE CIRCUIT ON THE SURGICAL SIDE, AIR WAS OBSERVED IN THE TOP OF THE AIR CHAMBER OF THE BCD VANGUARD CARDIOPLEGIA HEAT EXCHANGER. THE EVENT OCCURRED WHILE THE PUMP WAS STOPPED. THE PROCEDURE CONTINUED AFTER CHANGEOUT OF THE CARDIOPLEGIA HEAT EXCHANGER. 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
    1002850 BCD VANGUARD N/S RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA 050228J 2212210042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown