BEUDAMED
    FDA Recall Terminated

    CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)

    Recall: Z-1634-2014 · Initiated May 9, 2014

    Recall

    Recall Number
    Z-1634-2014
    Event Number
    68240
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DRY
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    May 9, 2014
    Posted
    May 19, 2014
    Terminated
    July 11, 2014
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)

    Reason

    There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing accep

    Action

    On 5/9/14, TCVS placed a phone call to the one affected customer regarding the recall. The phone call explained the reason for the recall, identification of affected product, potential hazard, and instructions for return of affected product.

    Distribution

    one customer in IA

    Quantity

    1