BEUDAMED
    FDA Enforcement Class II 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 · Reported May 28, 2014

    Enforcement

    Recall Number
    Z-1634-2014
    Event ID
    68240
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 28, 2014
    Initiation Date
    May 9, 2014
    Classification Date
    May 19, 2014
    Termination Date
    July 11, 2014
    Address
    6200 Jackson Rd, N/A, Ann Arbor, MI, 48103-9586, United States

    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

    Code Info

    Catalog Number or Part Number 145891 500AVHCT Serial Number: BPM SN 8015552 (installed into CDI 500 Monitor SN 3535)

    Distribution

    one customer in IA

    Quantity

    1