BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 13234914 · Received January 12, 2022

    Report

    Report Number
    9680841-2022-00002
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    December 13, 2021
    Report Date
    May 23, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS IDENTIFIED PRIOR TO ANY PATIENT INVOLVEMENT. THE BCD VANGUARD (ITEM 050228, LOT NUMBER 2103020075) IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO CONVENIENCE PACK MANUFACTURED BY A (B)(6) ASSEMBLER (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 ITALIA MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE EVENT OCCURRED IN (B)(6). THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION AND NOT YET RECEIVED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT STATING THAT THE FILLING VOLUME OF THE VANGUARD SUDDENLY DROPPED DURING PRIMING PHASE. NO VIDEO AS EVIDENCE OF THE REPORTED ISSUE WAS PROVIDED, RETURNED PART WAS VISUALLY INSPECTED AND NO DAMAGE NOR DEFORMATIONS WERE NOTICED ON THE UMBRELLA VALVE, WHICH WAS FOUND TO BE CORRECTLY SEATED IN ITS HOUSING. A SUBSEQUENT FUNCTIONAL TEST WITH WATER WAS PERFORMED TO VERIFY FUNCTIONAL CONFORMITY OF THE DEVICE. LABORATORY TEST CONFIRMED THE DEVICE BEHAVED AS EXPECTED. ANALYSIS OF COMPLAINTS DATABASE REVEALED NO OTHER CASES NOTIFIED FOR BATCH CONCERNED FROM THE MARKET. BASED ON AVAILABLE INFORMATION, IT CANNOT BE EXCLUDED THAT THE MOST LIKELY ROOT CAUSE OF COMPLAINED PHENOMENON WAS ASSIGNED TO UNINTENDED APPLICATION OF NEGATIVE PRESSURE INSIDE THE CIRCUIT DURING PRIMING, THIS CREATING PRESSURE CONDITIONS SUCH THAT AIR IS GENERATED INSIDE THE DEVICE. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, AFTER COMPLETION OF PRIMING, THE LIQUID LEVEL IN THE VANGUARD HAS DROPPED. THE ISSUE WAS IDENTIFIED PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887175 SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM CARDIOPLEGIA HEAT EXCHANGER DTN SORIN GROUP ITALIA SRL 2103020077 OR 2104060120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown