BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.

    Recall: Z-1337-2019 · Initiated April 18, 2019

    Recall

    Recall Number
    Z-1337-2019
    Event Number
    82630
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 18, 2019
    Terminated
    May 20, 2020
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.

    Reason

    The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.

    Action

    The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2019 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to take the following actions: 1. Review this Medical Device Recall notice. 2. Assure that all users have received notice of this issue, and prominently display this notice where all users may access it. 3. Continue use of the device in conjunction with the backup external mechanical flowmeter found in the Terumo System 1 Accessory Kit. 4. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 5. Terumo CVS will contact users to schedule the field correction activities. Note: Terumo CVS recommends that users continue using their Terumo System 1 with EGPS, with the required backup external mechanical flowmeter, while waiting for this correction. Customers with questions are directed to the following: Terumo CVS Customer Service: 1.800.521.2818 Monday - Friday 8 a.m. to 6 p.m. ET Recall Fax: 1.734.741.6149

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.

    Quantity

    1258