BEUDAMED
    FDA Enforcement Class II Ongoing

    PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

    Recall: Z-0993-2022 · Reported May 4, 2022

    Enforcement

    Recall Number
    Z-0993-2022
    Event ID
    89823
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2022
    Initiation Date
    March 15, 2022
    Classification Date
    April 22, 2022
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

    Reason

    This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.

    Code Info

    a) 955558, UDI 07332414124359, b) 955627, UDI 07332414124700, c) 955701, UDI 07332414125844, All Serial Numbers

    Distribution

    Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

    Quantity

    3513 units