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Terminated

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

FDA Recall Z-1439-2017 · Posted None

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeMEA
Date Initiated2016-10-31
Date Terminated2019-07-15
Product Quantity20

Reason for Recall

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.

Firm 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 [email protected]. For further questions please call (651) 633-2556.

Root Cause

Software design

Distribution Pattern

Internationally to Finland

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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