—#152490

Product

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

FDA product code: MEA — Pump, Infusion, Pca
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929

Distribution

Distribution pattern: Internationally to Finland

Timeline

Recall initiated: 2016-10-31
Terminated: 2019-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152490. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.