BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD CARDIOPLEGIA HEAT EXCHANGER & SETS (UNCOATED)

    MDR report key: 9284147 · Received November 6, 2019

    Report

    Report Number
    9680841-2019-00038
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 2, 2019
    Report Date
    October 7, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED DEVICE IS NOT AVAILABLE FOR INVESTIGATION. THEREFORE NO INVESTIGATION COULD BE PERFORMED ON THE COMPLAINED DEVICE. THE BATCHES OF THE TUBING SET AND OF THE DEVICE ARE UNKNOWN. THEREFORE, NOR ANY DEVICE COULD BE PULLED OUT FROM INVENTORY FOR INVESTIGATION NEITHER ANY DHR REVIEW COULD BE PERFORMED. NO DIGITAL EVIDENCE (PHOTOGRAPHIC OR VIDEO) WAS PROVIDED BY THE CUSTOMER TO INVESTIGATE THE CLAIMED ISSUE. IN ABSENCE OF FURTHER EVIDENCE NO DEFINITIVE CONCLUSION CAN BE REACHED ON THE ROOT CAUSE OF THE EVENT. IN CASE FURTHER INFORMATION USEFUL FOR THE INVESTIGATION WOULD BE PROVIDED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS NO DEVICE MALFUNCTION COULD BE CONFIRMED, NO CORRECTIVE ACTION WILL BE UNDERTAKEN. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE BCD VANGUARD (ITEM 050228, LOT NUMBER UNKNOWN) IS A NON-STERILE DEVICE THAT WAS ASSEMBLED INTO CONVENIENCE PACK (CATALOG NUMBER C24308) 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 (B)(4) MANUFACTURES THE SORIN BIOMEDICA SMARXT BCD VANGUARD. THE INCIDENT OCCURRED IN (B)(6). THE INVOLVED DEVICE IS NOT AVAILABLE FOR INVESTIGATION. 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 (B)(4) HAS RECEIVED A REPORT THAT, DURING PRIMING, AIR ACCUMULATED IN THE TOP OF THE BCD VANGUARD CARDIOPLEGIA HEAT EXCHANGER. THE DEVICE WAS CHANGED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUE. THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082355 VANGUARD CARDIOPLEGIA HEAT EXCHANGER & SETS (UNCOATED) CARDIOPLEGIA HEAT EXCHANGER DTN SORIN GROUP ITALIA SRL

    Patients

    Seq Age Sex Outcome Treatment
    1