BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPLEGIA HEAT EXCHANGER

    MDR report key: 10008826 · Received April 29, 2020

    Report

    Report Number
    9680841-2020-00007
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    March 17, 2020
    Report Date
    March 30, 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

    THE INVOLVED BCD VANGUARD HAS BEEN RECEIVED AT LIVANOVA FACILITY FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED UNIT REVEALED THAT THE DEVICE WAS RETURNED WITHOUT THE WHITE PROTECTIVE CAP MOUNTED ON THE UMBRELLA VALVE ON TOP PORTION. NO DEFORMATION OR DAMAGES COULD BE IDENTIFIED. DURING A SIMULATED USE TEST, AIMED TO SIMULATE THE CLAIMED AIR ACCUMULATION (DE-PRIMING) IN THE UNIT, THE RETURNED DEVICE PERFORMED AS EXPECTED. MANUFACTURING RECORDS WERE VERIFIED AND FOUND TO BE CONFORMING TO SPECIFICATIONS. NO FURTHER SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR NOTICED PRODUCT LOT. BASED ON COLLECTED EVIDENCES, NO SPECIFIC MALFUNCTION OF THE DEVICE HAS BEEN IDENTIFIED. AS THE CLAIMED ISSUE COULD NOT BE REPRODUCED, NO RELATIONSHIP BETWEEN THE EVENT AND ANY DEVICE-RELATED MALFUNCTION COULD BE ESTABLISHED, NO ROOT CAUSE ANALYSIS COULD BE PERFORMED, AND NO CORRECTIVE ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE SORIN BIOMEDICA SMARXT BCD VANGUARD (ITEM 050228, LOT NUMBER 1903280047) 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 SORIN BIOMEDICA SMARXT BCD VANGUARD 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 IN (B). THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE NOT YET RETURNED

    Description of Event or Problem · 1

    SORIN GROUP(B)(4) HAS RECEIVED A REPORT THAT, AFTER PRIMING, AIR WAS SEEN IN THE TOP PART OF THE BCD VANGUARD CARDIOPLEGIA EXCHANGER AND A LEAK OF PRIMING SOLUTION WAS IDENTIFIED IN OPERATIVE FIELD. THE ISSUE OCCURRED PRIOR TO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472367 CARDIOPLEGIA HEAT EXCHANGER SORIN BCD VANGUARD BLOOD CARDIOPLEGIA SYSTEM DTN SORIN GROUP ITALIA SRL 1904180140

    Patients

    Seq Age Sex Outcome Treatment
    1