BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

    MDR report key: 11273152 · Received February 3, 2021

    Report

    Report Number
    9680841-2021-00002
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 6, 2021
    Report Date
    March 29, 2021
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT THAT, POST PROCEDURE DURING THE WATER LINES REMOVAL, BLOOD MIXED WITH WATER WAS FOUND IN HEATER COOLER CANISTER FOR THE CARDIOPLEGIC CIRCUIT. THERE IS NO REPORT OF PATIENT INJURY. THE ISSUE COULD BE ALREADY CONFIRMED BASED ON VISUAL INSPECTION OF THE PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CUSTOMERS. THE BCD VANGUARD WAS REQUESTED FOR INVESTIGATION. THE HEAT EXCHANGER MODULE OF THE BCD VANGUARD IS COMPOSED OF A PLEATED METAL SHEET WHICH SEPARATES THE BLOOD AND THE WATER COMPARTMENTS. ANALYSIS OF THE METAL SHEET REVEALED THE PRESENCE OF A HOLE IN THE METAL LAYER. A REVIEW OF DHR DID NOT IDENTIFY ANY NON-CONFORMITY. REVIEW OF THE LIVANOVA COMPLAINT DATABASE CONFIRMED NO OTHER SIMILAR EVENT WAS NOTIFIED RELEVANT TO SAME LOT/ ITEM PART NUMBER. DURING MANUFACTURING, 100% OF THE BCD VANGUARD ARE LEAK TESTED AT THE FINAL ASSEMBLY STEP. THIS TYPE OF FAILURE IS DETECTABLE BY IN-LINE MANUFACTURING TEST. IF A UNIT FAILS THIS TEST, THE UNIT IS IDENTIFIED AND DISPOSED. LIVANOVA BELIEVE THE MOST PROBABLE ROOT CAUSE OF THE ISSUE WAS AN ISOLATED OPERATOR ERROR AT THE IDENTIFICATION OF THE FAILING UNITS THAT WAS THEN INCORRECTLY NOT DISPOSED. THE RESIDUAL RISK IS STILL ACCEPTABLE. AT THE MOMENT, NO SPECIFIC ACTION WILL BE UNDERTAKEN, LIVANOVA WILL MAINTAIN MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION HAS BEEN PROVIDED. THE BCD VANGUARD IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE LOT OF THE BCD VANGUARD IS PENDING. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE BCD VANGUARD WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE INVOLVED BCD VANGUARD IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE BCD VANGUARD IS REGISTERED IN THE USA (510(K) NUMBER: K021830). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE BCD VANGUARD. THE INCIDENT OCCURRED IN (B)(6). THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. AN UNUSED DEVICE FROM THE SAME LOT NUMBER HAS BEEN RETURNED BY THE CUSTOMER. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, AT THE END OF A PROCEDURE, WHEN CUSTOMER REMOVED WATER LINES FROM CARDIOPLEGIA HEAT EXCHANGER VANGUARD, NOTICED IN THE SUCTION CANISTER ON HEATER COOLER. THERE WAS NO INDICATION OF ANY ISSUE DURING THE PROCEDURE. PATIENT WAS ADMINISTERED OF EXTRA ANTIBIOTICS. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169387 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR SORIN GROUP ITALIA SRL

    Patients

    Seq Age Sex Outcome Treatment
    1