BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 11419575 · Received March 5, 2021

    Report

    Report Number
    9680841-2021-00005
    Event Type
    Malfunction
    Date Received
    March 5, 2021
    Date of Event
    January 27, 2021
    Report Date
    April 28, 2021
    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

    LIVANOVA RECEIVED A REPORT STATING THAT AIR WAS FOUND IN THE UPPER PART OF BCD VANGUARD AFTER PRIMING. ACCORDING TO PROVIDED INFORMATION, AIR WAS NOTICED UPON COMPLETION OF PRIMING, WHEN THE NEGATIVE PRESSURE WAS APPLIED INTENTIONALLY. THERE WAS NO REPORT OF PATIENT INJURY. FOLLOW UP COMMUNICATION WITH THE CUSTOMER CLARIFIED THE PRIMING PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CUSTOMER INTENTIONALLY APPLIED NEGATIVE PRESSURE TO THE DEVICE TO VERIFY IF AIR WAS INTAKE. THIS TEST IS NOT REPORTED IN THE PRODUCT IFU. TWO OTHER SIMILAR COMPLAINTS WERE SUBMITTED BY THE SAME CUSTOMER: THE THREE (3) EVENTS ARE ASSOCIATED TO TWO (2) DIFFERENT PRODUCT LOTS. IN ALL THREE (3) EVENTS, THE CUSTOMER CONFIRMED TO HAVE APPLIED NEGATIVE PRESSURE TO THE DEVICE. LIVANOVA BELIEVES THE REPORTED AIR PRESENCE WAS CAUSED BY THE APPLICATION OF NEGATIVE PRESSURE AND IT IS NOT ASCRIBABLE TO ANY DEVICE MALFUNCTION. THE RISK IS ACCEPTABLE. NO CORRECTIVE ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS IDENTIFIED PRIOR TO ANY PATIENT INVOLVEMENT. THE BCD VANGUARD (ITEM 050228, LOT NUMBER 2001290058 OR 2004080083) 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 (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.

    Description of Event or Problem · 1

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, AFTER COMPLETION OF PRIMING, THE BOTTLE OF THE CARDIOPLEGIA SOLUTION WAS LOWERED BELOW THE BCD VANGUARD AND NEGATIVE PRESSURE WAS APPLIED INTENTIONALLY. THEN IT WAS CONFIRMED THAT AIR WAS PRESENT IN UPPER PART OF THE DEVICE. MEDICAL TEAM ELECTED TO CHANGE OUT THE CIRCUIT. THE ISSUE WAS IDENTIFIED PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319872 SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM CARDIOPLEGIA HEAT EXCHANGER DTN SORIN GROUP ITALIA SRL 2001290055 OR 2004080084

    Patients

    Seq Age Sex Outcome Treatment
    1