BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPLEGIA HEAT EXCHANGER

    MDR report key: 9510679 · Received December 23, 2019

    Report

    Report Number
    9680841-2019-00045
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    November 20, 2019
    Report Date
    April 15, 2020
    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

    H.10: SORIN GROUP ITALIA MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE EVENT OCCURRED SHIBATA, JAPAN. THE COMPLAINED BCD VANGUARD WAS RETURNED TO LIVANOVA FOR INVESTIGATION. DURING VISUAL INSPECTION IT HAS IDENTIFY THE WHITE PROTECTIVE CAP WAS DISASSEMBLED FROM THE UMBRELLA VALVE ON TOP AREA AND WAS LOOSE INSIDE PACKAGE. VISUAL INSPECTION ON UMBRELLA VALVE FOUND NO DEFORMATION NOR ANY OBVIOUS DAMAGE. THE BCD VANGUARD WAS FILLED WITH BLUE METHYLENE DRY SOLUTION AND VERIFIED IF AIR WAS ENTERING IN THE DEVICE. LABORATORY TEST COULD NOT REPRODUCE THE CLAIMED AIR INTAKE. HOWEVER, A LEAK WAS IDENTIFIED BY THE TOP PORTION OF AIR CHAMBER, IN PROXIMITY TO WELDING PROFILE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. BASED ON PREVIOUS INVESTIGATION, THE ROOT CAUSE OF THIS TYPE OF LEAK WAS A WEAKENING OF ULTRASONIC WELDING OF POLYCARBONATE LID AND BODY OF AIR CHAMBER. TO FURTHER DECREASE THE FREQUENCY OF THIS TYPE OF LEAKAGES, MATCHING OF THE AIR CHAMBER COMPONENTS HAS BEEN IMPROVED AND A MOULD MAINTENANCE HAVE BEEN PERFORMED. THE FREQUENCY OF THIS TYPE OF LEAK IS LOW. NO CORRECTIVE ACTION WILL BE UNDERTAKEN. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE BCD VANGUARD (ITEM 050228, LOT NUMBER 1810260092) 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. 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 EVENT OCCURRED (B)(6). 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 · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, AFTER PRIMING OF THE BCD VANGUARD CARDIOPLEGIA EXCHANGER, AIR WAS SEEN ON THE TOP PART OF THE EXCHANGER AND IN THE OPERATOR CIRCUIT. THE EXCHANGER WAS REPLACED. THE ISSUE OCCURRED PRIOR TO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306554 CARDIOPLEGIA HEAT EXCHANGER SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM DTN SORIN GROUP ITALIA SRL 1810260092

    Patients

    Seq Age Sex Outcome Treatment
    1