BEUDAMED
    FDA Recall Open, Classified

    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

    Recall: Z-2615-2021 · Initiated September 8, 2021

    Recall

    Recall Number
    Z-2615-2021
    Event Number
    88664
    Firm
    Datascope Corp.
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 8, 2021
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    Description

    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

    Reason

    The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.

    Action

    On Wednesday, September 8, 2021, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that all lots of Maquet Cardiosave Hybrid experience the following issue: Unexpected Shutdown Upon Battery Removal. Immediate Actions to be taken by Customers: To ensure that the Cardiosave Hybrid is not susceptible to shutdown during the removal of a battery, users should not eject a battery when: - There is a singulat battery in either battery charging bay and unused battery bay is empty. - The battery is charging on AC power (indicated by a flashing LED on the battery pack). Additionally, the user can prevent the issue by ensuring that a battery is inserted into each of the two battery bays. Should a charging battery be ejected inadvertently, the unit will automatically switch over to the second battery, thus preventing system shutdown. Furthermore, Datascope/Getinge is developing a software correction to address this issue. A Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

    Distribution

    Nationwide domestic distribution. Foreign distribution worldwide.

    Quantity

    3969 total (US), 3550 total (OUS)