BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 8281012 · Received January 28, 2019

    Report

    Report Number
    9680841-2019-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    December 3, 2018
    Report Date
    April 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

    PATIENT INFORMATION WAS NOT PROVIDED. THE BCD VANGUARD (ITEM 050229, LOT NUMBER UNKNOWN) 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. SORIN GROUP (B)(4) MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE HOSPITAL WHERE THE INCIDENT OCCURRED WAS (B)(6). SORIN GROUP (B)(4) WAS INFORMED BY THE DISTRIBUTOR (B)(4). 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.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE HOSPITAL WHERE THE INCIDENT OCCURRED WAS TOKUSHIMA UNIVERSITY HOSPITAL, TOKUSHIMA, JAPAN. SORIN GROUP ITALIA WAS INFORMED BY THE DISTRIBUTOR SENKO, TOKYO, 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.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, AFTER INFUSION OF CARDIOPLEGIC SOLUTION, DURING THE CARDIOPLEGIA STANDBY, AIR WAS DETECTED IN THE UPPER PART OF THE BCD VANGUARD. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73527 SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM CARDIOPLEGIA HEAT EXCHANGER DTR SORIN GROUP ITALIA SRL

    Patients

    Seq Age Sex Outcome Treatment
    1