Smiths Medical Corrects CADD-Solis Software

FDA recently classified Smith Medicals recall of its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps as Class I after it was found that certain previous software versions may cause potential errors. The recall is considered a correction, not product removal.

The CADD-Solis and CADD-Solis VIP are indicated for intravenous infusions including intra-arterial, subcutaneous, intraperitoneal, close to nerves, intraoperative, epidural space or subarachnoid spaces. Additionally, the pumps can be used for treatments that require continuous infusion rates, intermittent larger dose, or patient-controlled on-demand doses.

On February 27, Smiths sent all affected customers an Urgent Medical Device Correction Letter informing them that the company was correcting software for the two pumps after it was found that issues may occur when using CADD-Solis and CADD-Solis VIP without the latest software versions.

When using software versions before V4.3, Smiths said the devices may fail to alarm when there is an upstream occlusion, have unresponsive stop and power keys, the air detector could fail to start in manual mode, potential failure to alarm for Single Bubble Air Detection, system error codes do not display at power up, have no audible alarm sound, Air in Line Detection threshold may be too high, and there may be problems logging into PharmGuard if passwords include special characters.

If an error were to occur while using an effected device, there may be serious adverse health consequences related to delay, interruption, under or over administration of therapy, or death.

The company said that many of the issues included in the correction have already been fixed through previous software updates and the corrections will be carried through all subsequent releases.