BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPLEGIA HEAT EXCHANGER

    MDR report key: 9510677 · Received December 23, 2019

    Report

    Report Number
    9680841-2019-00044
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    November 27, 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

    SORIN GROUP ITALIA MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE EVENT OCCURRED (B)(6). THE COMPLAINED BCD VANGUARD WAS RETURNED TO LIVANOVA FOR INVESTIGATION. VISUAL INSPECTION FOUND NO PROBLEM NOR ANY DEFECT. THE BCD VANGUARD WAS FILLED TO VERIFY 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. BASED ON INVESTIGATION RESULTS, NO DIRECT RELATIONSHIP BETWEEN THE COMPLAINED EVENT AND ANY DEVICE RELATED MALFUNCTION HAS BEEN ESTABLISHED. AS NO SPECIFIC FAILURE OF THE DEVICE TO MEET SPECIFICATIONS HAS BEEN REPRODUCED AND CONFIRMED, NO CORRECTIVE ACTION WILL BE TAKEN IN PLACE FOR THE TIME BEING. 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 · 1

    THE EVENT OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE BCD VANGUARD (ITEM 050228, LOT NUMBER 1811260162) 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
    1306550 CARDIOPLEGIA HEAT EXCHANGER SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM DTN SORIN GROUP ITALIA SRL 1810260092

    Patients

    Seq Age Sex Outcome Treatment
    1