BEUDAMED
    FDA Recall Terminated

    CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    Recall: Z-0142-2012 · Initiated September 23, 2011

    Recall

    Recall Number
    Z-0142-2012
    Event Number
    59582
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DRY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 23, 2011
    Posted
    October 31, 2011
    Terminated
    April 11, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    Reason

    Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored.

    Action

    Terumo Cardiovascular Systems Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" notice dated September 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides information on what to do in the event of a failure of the device. Additionally, a Customer Response Form was attached to the letter for customers to complete and return. Terumo CVS will schedule the return of affected products for inspection and replacement of defective parts. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Chile, Japan, Philippines, and Thailand.

    Quantity

    432