BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS

    MDR report key: 15864360 · Received November 25, 2022

    Report

    Report Number
    9680841-2022-00053
    Event Type
    Malfunction
    Date Received
    November 25, 2022
    Date of Event
    September 12, 2022
    Report Date
    March 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

    VERIFICATION OF PRODUCTION RECORDS CONFIRMED THAT NOTICED LOT WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. REVIEW OF LIVANOVA COMPLAINTS DATABASE IDENTIFIED NO OTHER CASES NOTIFIED FROM THE MARKET FOR THIS TYPE OF PROBLEM. CONSIDERING THAT PHENOMENON WAS REPRODUCED DURING MOCK DEPRIMING TEST AT SENKO FACILITY WITHOUT ANY APPLICATION OF NEGATIVE PRESSURE, REPORTED EVENT WAS TRACED BACK TO PINCHED OR MISPLACED UMBRELLA VALVE. IN THIS REGARD, IT CANNOT BE EXCLUDED THAT THE UMBRELLA VALVE WAS NOT PERFECTLY SEATED IN ITS DEDICATED HOUSING UPON RECEIPT OF THE UNIT AT CUSTOMER SITE, MOST LIKELY DUE TO ACCIDENTAL MECHANICAL STRESSES APPLIED DURING THE TRANSPORTATION OF THE PRODUCT. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WERE NOT PROVIDED. 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. THE PRODUCT ITEM 050228J IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE BCD VANGUARD ITEM 050228, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K934847). THE COMPLAINED BCD VANGUARD IS A NON STERILE COMPONENT SOLD TO AN ASSEMBLER IN JAPAN. THE MANUFACTURING DATE OF THE STERILE DEVICE IS UNKNOWN. SORIN GROUP ITALIA MANUFACTURES THE BCD VANGUARD. THE INCIDENT OCCURRED IN JAPAN. FOLLOW UP WITH THE CUSTOMER CLARIFIED THAT: - WHEN THE EVENT OCCURRED, THE UNIT WAS FILLED WITH BLOOD, AND THE THREE-WAY STOPCOCK WAS NOT OPENED. THE CUSTOMER THINKS THAT THE EVENT WOULD NOT OCCUR DUE TO A POSITIONAL DROP. - THE UNIT WAS TESTED BY THE JAPANESE ASSEMBLER AND WATER IN THE CIRCUIT LEAKED OUT. ACCORIND TO SUBSEQUENT CLARIFICATION, AFTER THE FILLING OF THE UNIT, CLAMP ON INLET PORT WAS RELEASED AND THE LEVEL OF FLUID INSIDE THE UNIT DECREASED DUE TO AIR INTAKE FROM TOP AREA. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, WHEN THE AORTIC CLAMP WAS OPENED AND THE PUMP WAS TURNED OFF, AIR WAS OBSERVED IN THE UPPER PART OF THE UNIT. SINCE A SMALL AMOUNT OF AIR WAS ALSO OBSERVED IN THE OPERATIVE FIELD CIRCUIT, AIR RELEASE WAS PERFORMED. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686827 NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS RESERVOIR DTN SORIN GROUP ITALIA SRL 2105250099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown