BEUDAMED
    FDA Recall Open, Classified

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

    Recall: Z-1023-2023 · Initiated December 12, 2022

    Recall

    Recall Number
    Z-1023-2023
    Event Number
    91343
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DTZ
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    December 12, 2022
    Posted
    January 27, 2023
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

    Reason

    An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

    Action

    Medtronic initially notified consignees on 12/12/2022 and followed up with an updated notification on 12/21/2022. Consignees were advised of two options: 1. Continue to use the Affinity Fusion Oxygenator without using the TMA (use other conventional perfusion circuit temperature monitoring methods); or 2. Continue to use the Affinity Fusion Oxygenator and the TMA for arterial temperature monitoring. Ensure there is minimal torque applied to the oxygenator TMA when attaching or detaching the Temperature Probe (Product Number ATP210). Also, minimize manipulation of the TMA-probe connection during the clinical procedure. Consignees were also advised to complete and return the Customer Confirmation Form, and notify personnel or facilities were affected units are located. On about 02/10/2023, Medtronic initiated an expansion and notified customers. Instructions in the customer letter remained the same.

    Distribution

    Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala, Honduras, Hungary, Iceland, Indonesia, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, Turkmenistan, Uganda, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Yemen.

    Quantity

    2,937 units