FDA Announces Smiths Medical’s Correction for CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump Software
On August 6, 2024, the U.S. Food and Drug Administration (FDA) announced that (https://www.fda.gov/medical-devices/medical-device-recalls/ambulatory-infusion-pump-software-correction-smiths-medical-issues-correction-cadd-solis-and-cadd) Smiths Medical is issuing a correction recall for its CADD-Solis Ambulatory Infusion Pump because of multiple issues related to outdated software. The FDA said that the recall involves correcting certain devices (https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall), not removing them from where they are used or sold.
The FDA has identified it as the most serious type of recall, where continued use without correction may cause serious injury or death. The agency advised that (https://www.fda.gov/medical-devices/medical-device-recalls/ambulatory-infusion-pump-software-correction-smiths-medical-issues-correction-cadd-solis-and-cadd) use of the affected products may cause serious adverse health consequences related to delay, interruption, under- or over-administration of therapy, or death.
The recall affects CADD-Solis Ambulatory Infusion Pumps with the following software:
- CADD-Solis various software versions earlier than v.4.2
- CADD-Solis VIP various software versions earlier than v.1.6
- PharmGuard server software versions earlier than v.2.6
See the full list of affected products (https://www.fda.gov/medical-devices/medical-device-recalls/ambulatory-infusion-pump-software-correction-smiths-medical-issues-correction-cadd-solis-and-cadd?utm_medium=email&utm_source=govdelivery#affectedproducts) for the unique device identifier (UDI) and model numbers.
Smiths Medical said that (https://www.fda.gov/medical-devices/medical-device-recalls/ambulatory-infusion-pump-software-correction-smiths-medical-issues-correction-cadd-solis-and-cadd) it is correcting the software because of multiple issues that may happen with versions before v4.3, including:
- Alarm failure for upstream occlusions
- Unresponsive stop and power keys
- Air detector failure in manual mode
- Alarm failure for single bubble air detection
- System error codes do not display at power up
- No audible alarm sound
- Air in line detection threshold may be too high
- Problems logging into PharmGuard if passwords include special characters
To date, Smiths Medical said it had received one reported injury and no reports of death.
The company advised that anyone using the affected pumps ensure that the most recent CADD software is installed. Smiths Medical said that it already corrected many of the issues during previous software updates, which were announced during a February 27, 2024, urgent medical device correction letter (https://usme.com/wp-content/uploads/2024/03/Smiths-Medical-CADD-Solis-Letter.pdf). Those corrections were carried forward to all subsequent software releases.
U.S. customers with questions about the recall should contact TSC.Support@icumed.com (mailto:TSC.Support@icumed.com) or 800-241-4002, option 3, 4.
Healthcare professionals and consumers may report adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) they experience with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.