Events

Recall of CADD Solis VIP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76189
  • Event Risk Class
    Class 2
  • Event Number
    Z-1439-2017
  • Event Initiated Date
    2016-10-31
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152490
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, pca - Product Code MEA
  • 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.
  • Action
    Smiths Medical sent an Urgent Medical Device Field Safety Notice dated October 26, 2016, via FedEx on October 31, 2016. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to contact the Smiths Medical Service & Repair Department for the software to be loaded and to complete the Recall Confirmation Form and return it to Smith Medical via e-mail to FCA.Response@Smiths-medical.com. For further questions please call (651) 633-2556.

Device

CADD Solis VIP
  • Model / Serial
    1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Internationally to Finland
  • Product Description
    CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA