BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 8444637 · Received March 22, 2019

    Report

    Report Number
    9680841-2019-00014
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    January 11, 2019
    Report Date
    May 20, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTN
    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 NANKOKU, JAPAN. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE COMPLAINED BCD VANGUARD WAS RETURNED TO SORIN ITALIA FOR INVESTIGATION. VISUAL INSPECTION FOUND NOT OBVIOUS PROBLEM NOR DEFECT. THE BCD VANGUARD WAS FILLED AND VERIFIED IF AIR WAS ENTERING IN THE DEVICE. LABORATORY TEST COULD NOT REPRODUCE THE CLAIMED PROBLEM. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. LIVANOVA EXPERIENCE INDICATES THAT THE PROBLEM COULD BE RELATED TO A NOT-PERFECTLY SEATED UMBRELLA VALVE. THE REASONS FOR THE INCORRECT SEATING OF THE VALVE MIGHT BE AN ACCIDENTAL EXCESSIVE MECHANICAL STRESS DUE TO SHIPPING/TRANSPORTATION. AS THE FREQUENCY OF THIS TYPE OF EVENT IS LOW, NO CORRECTIVE ACTION WILL BE UNDERTAKEN. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE BCD VANGUARD (ITEM 050228, LOT NUMBER 180328006) 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. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING PRIMING, AIR WAS SEEN AT THE TOP OF THE CARDIOPLEGIA HEAT EXCHANGER BCD VANGUARD. THE ISSUE OCCURRED PRIOT TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236351 SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM CARDIOPLEGIA HEAT EXCHANGER DTN SORIN GROUP ITALIA SRL 1803280063

    Patients

    Seq Age Sex Outcome Treatment
    1