BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BIOMEDICA SMARXT BCD VANGUARD

    MDR report key: 9348157 · Received November 20, 2019

    Report

    Report Number
    9680841-2019-00039
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    October 22, 2019
    Report Date
    October 23, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10 SORIN GROUP ITALIA MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE INCIDENT OCCURRED IN BOSTON, MASSACHUSETTS, USA. THE COMPLAINED BCD VANGUARD WAS RETURNED TO LIVANOVA FOR INVESTIGATION. VISUAL INSPECTION FOUND NO PROBLEM NOR ANY DEFECT. THE BCD VANGUARD WAS FILLED AND VERIFIED 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.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WERE NOT PROVIDED. THE SORIN BIOMEDICA SMARXT BCD VANGUARD (ITEM 050229, LOT NUMBER 1905200076) IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO CONVENIENCE PACK CATALOG NUMBER 627164801 LOT 1924100032 AND STERILIZED BEFORE DISTRIBUTION AND USE IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE SORIN BIOMEDICA SMARXT BCD VANGUARD WAS ASSEMBLED INTO A CONVENIENCE PACK DISTRIBUTED IN THE USA. THE NON-STERILE CARDIOPLEGIA HEAT EXCHANGER IS ALSO DISTRIBUTED IN THE USA (510(K)NUMBER: K021830). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE CARDIOPLEGIA HEAT EXCHANGER WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE INCIDENT OCCURRED IN (B)(6). THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 1

    LIVANOVA RECEIVED A REPORT THAT, DURING A PROCEDURE, AIR WAS SEEN IN THE TOP PART OF THE BCD VANGUARD CARDIOPLEGIA HEAT-EXCHANGER- THE MEDICAL TEAM ELECTED TO CHANGE-OUT THE DEVICE THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143140 SORIN BIOMEDICA SMARXT BCD VANGUARD HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR SORIN GROUP ITALIA SRL 1905200076

    Patients

    Seq Age Sex Outcome Treatment
    1