BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCD VANGUARD

    MDR report key: 13666121 · Received March 4, 2022

    Report

    Report Number
    9680841-2022-00014
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 2, 2022
    Report Date
    May 4, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INFORMATION HAS BEEN PROVIDED. THE 3 COMPLAINED BCD VANGUARD CARDIOPLEGIA HEAT-EXCHANGERS ARE A NON-STERILE DEVICES ASSEMBLED INTO 2 DIFFERENT LOTS (2200600024 AND 2135400017) OF STERILE CONVENIENCE PACK ITEM 044009103 THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE FOR LOT 2200600024 OF CONVENIENCE PACK ITEM 044009103 IS 31 JANUARY 2024. THE UNIQUE IDENTIFIER (UDI) NUMBER IS (B)(4). THE EXPIRATION DATES FOR LOT 2135400017 OF CONVENIENCE PACK ITEM 044009103 IS 31 DECEMBER 2023. THE UNIQUE IDENTIFIER (UDI) NUMBER IS (B)(4). THE COMPLAINED BCD VANGUARD CARDIOPLEGIA HEAT-EXCHANGERS ARE NON-STERILE COMPONENTS ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE BCD VANGUARD CARDIOPLEGIA HEAT-EXCHANGER IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K934847). THE DEVICE MANUFACTURE FOR LOT 2200600024 OF CONVENIENCE PACK ITEM 044009103 IS 6 JANUARY 2022 AND LOT 2135400017 OF CONVENIENCE PACK ITEM 044009103 IS 20 DECEMBER 2021. SORIN GROUP (B)(4) MANUFACTURES THE BCD VANGUARD CARDIOPLEGIA HEAT-EXCHANGERS. THE INCIDENT OCCURRED IN (B)(6), UNITED STATES OF AMERICA. THE INVOLVED DEVICES WERE NOT MADE AVAILABLE 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.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT STATING THAT THREE (3) CARDIOPLEGIA HEAT-EXCHANGERS BCD VANGUARD DRAWN AIR INTO THE DEVICE DURING CARDIOPLEGIA DELIVERY. PHOTOGRAPHIC EVIDENCE OF ONE DEVICE WAS PROVIDED. ALL 3 DEVICES WERE NOT AVAILABLE FOR INVESTIGATION. ATTEMPTS TO COLLECT INFORMATION ON THE OTHER TWO EVENTS WERE NOT SUCCESSFUL. THE DHR REVIEW CONFIRMED THE LOTS OF THE 3 UNITS WERE RELEASED CONFORMING TO SPECIFICATIONS. REVIEW OF THE LIVANOVA COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR EVENT IN THE LAST 12 MONTHS THUS CONFIRMING THESE ARE ISOLATED EVENTS AND NO SYSTEMATIC MANUFACTURING ISSUE CAN BE IDENTIFIED. BASED ON SIMILAR PREVIOUS EVENTS, AIR INTAKE IN THE TOP PART OF THE BCD VANGUARD HEAT-EXCHANGERS COULD BE RELATED TO: (I) PINCHED/MISPLACED UMBRELLA VALVE OR (II) APPLICATION OF NEGATIVE PRESSURE TO THE DEVICE BY THE CUSTOMER. SINCE THE DEVICE WAS NOT MADE AVAILABLE, THE FIRST ROOT CAUSE COULD NOT BE EXCLUDED. NO INFORMATION OF APPLICATION OF NEGATIVE PRESSURE WAS PROVIDED. SINCE NOT CLEAR ROOT CAUSE COULD BE ESTABLISHED AND THE RISK IS IN THE ACCEPTABLE REGION, NO ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA USA INC HAS BEEN INFORMED THAT, DURING PROCEDURES, 3 SEPARATE CARDIOPLEGIA UNITS ASSEMBLING BCD-VANGUARD IN, TOOK AIR DURING CARDIOPLEGIA DELIVERY. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705927 BCD VANGUARD RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA SRL 050228 2106280151

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown