CADD Solis VIP Ambulatory Infusion Pump Cl II

Company: Smiths Medical ASD, Inc.
Date of Enforcement Report 3/22/2017
Class lI:

PRODUCT

CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Recall Number Z-1439-2017

REASON
I20 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.

RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., St Paul, MN on 10/31/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
20

DISTRIBUTION
Internationally to Finland

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.