BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

    Recall: Z-2350-2021 · Initiated June 8, 2021

    Recall

    Recall Number
    Z-2350-2021
    Event Number
    88350
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 8, 2021
    Terminated
    June 28, 2022
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

    Reason

    intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

    Action

    Terumo notified the regional affiliate to address the single EPGS device in Panama via email on 6/8/21. Letter states reason for recall, health risk and action to take: Terumo CVS will execute a field correction to replace the one (1) affected EPGS device. A Terumo Representative will contact you to schedule the field correction activities. 1. Review this Medical Device Correction and assure the user has received notice of this issue. 2. A Terumo representative will contact the user to schedule the field correction activity. Note: Terumo CVS recommends that users continue using the affected Terumo System 1 while waiting for this correction. We encourage you to contact your local Terumo representative with any questions or concerns.

    Distribution

    International distribution in the country of Panama.

    Quantity

    1 unit OUS