BEUDAMED
    FDA Enforcement Class II Terminated

    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,

    Recall: Z-1439-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1439-2017
    Event ID
    76189
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    October 31, 2016
    Classification Date
    March 10, 2017
    Termination Date
    July 15, 2019
    Address
    1265 Grey Fox Rd, N/A, Saint Paul, MN, 55112-6929, United States

    Description

    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,

    Reason

    20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the incorrect message. The message indicates that a Patient Controlled Analgesia (PCA) dose is unavailable because the pump is running. It should indicate that the PCA dose is not available because the pump is stopped. The function of the pump is unchanged and no patient injury can occur since no drug is being delivered.

    Code Info

    1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.

    Distribution

    Internationally to Finland

    Quantity

    20