BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 8510135 · Received April 12, 2019

    Report

    Report Number
    9680841-2019-00017
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    February 19, 2019
    Report Date
    July 26, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE EVENT OCCURRED IN KASHIWA, JAPAN. SORIN GROUP ITALIA WAS INFORMED BY THE DISTRIBUTOR SENKO, TOKYO, JAPAN. INSPECTION OF THE RETURNED DEVICE CONFIRMED THE PRESENCE OF AN EXTRANOUS MATERIAL IN THE PRIMING SOLUTION BY THE BCD VANGUARD OUTLET CONNECTOR. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE PRESENCE OF THE EXTRANEOUS MATERIAL IS ASCRIBABLE TO A HUMAN ERROR DURING THE MANUFACTURING AND DURING THE SUBSEQUENT VISUAL INSPECTION STEPS THAT SHOULD HAVE IDENTIFIED THE EXTRANEOUS MATERIAL AND DISCARDED THE UNIT. TO PREVENT REOCCURRENCE, THE MANUFACTURING OPERATORS WILL BE RETRAINED. THE FREQUENCY OF THIS TYPE OF EVENT IS LOW. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE BCD VANGUARD (ITEM 050229, LOT NUMBER 1804170038) IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO CONVENIENCE PACK (CATALOG NUMBER UNKNOWN) THAT IS NOT DISTRIBUTED IN THE USA. THE LOT AND THE EXPIRY DATE (MM/DD/YYYY) OF THE COMPLAINED CONVENIENCE PACK ARE NOT KNOWN. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. AGE OF THE DEVICE: AS THE LOT IS UNKNOWN, STERILIZATION DATE COULD NOT BE DETERMINED AND THE AGE OF THE DEVICE COULD NOT BE CALCULATED. (B)(4). THE SORIN BIOMEDICA SMARXT BCD VANGUARD IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE NON-STERILE CARDIOPLEGIA HEAT EXCHANGER IS ALSO DISTRIBUTED IN THE USA (510(K) NUMBER: K934847). DEVICE MANUFACTURE DATE (MM/DD/YYYY) OF THE CONVENIENCE PACK: AS THE LOT NUMBER IS UNKNOWN, THE MANUFACTURE DATE COULD NOT BE DETERMINED. PER EXEMPTION NUMBER E2016005. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS BEEN INFORMED THAT, AFTER PRIMING, A WHITE PARTICLE WAS IDENTIFIED BY THE OUTLET OF THE CARDIOPLEGIA HEAT EXCHANGER BCD-VANGUARD. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303561 SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM CARDIOPLEGIA HEAT EXCHANGER DTR SORIN GROUP ITALIA SRL 1804170038

    Patients

    Seq Age Sex Outcome Treatment
    1