FDA-Device2017-03-22Class II
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Smiths Medical ASD, Inc.
Hazard
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.
Sold states
Internationally to Finland
Affected count
20
Manufactured in
1265 Grey Fox Rd, N/A, Saint Paul, MN, United States
Products
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1439-2017Don't want to check this manually?
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