This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
The FDA is aware that Smiths Medical has issued a letter to affected customers that certain lots of affected ambulatory infusion pumps have updated use instructions:
What to Do
On April 10, Smiths Medical sent all affected customers a letter recommending the following actions:
- Users should validate any wireless network changes or updates to hospital network settings with the pump/communication module to ensure compatibility of the wireless connection before deploying network setting changes or updates to the production environment.
- If this alarm recurs or is unable to be cleared by power cycling the pump, then revert to prior compatible network settings or turn off the wireless function of the communication module (which will not affect any of the pump’s clinical operations).
- Locate all affected products in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations.
- DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward your customer list to Sedgwick at icumedical8512@sedgwick.com. Sedgwick will notify customers with email addresses via email and will send physical notifications to customers without email addresses in order for them to complete the Response Form.
- Smiths Medical is sending this notification to all affected CADD-Solis customers and will address this issue via a software update. Smiths Medical will contact you to schedule the implementation of the software update once it is available.
Reason for Recall
Smiths Medical has become aware that CADD-Solis pumps may lose communication with the CADD wireless communication module if wireless network setting changes on the hospital network are not compatible with the CADD wireless communication module. This may result in a “Wireless Module Intermittent Connection” high priority alarm, which will stop an ongoing infusion.
If a “Wireless Module Intermittent Connection” high priority alarm is triggered, it will interrupt an active infusion. An interruption or delay of therapy can lead to serious patient injury or death, depending on the clinical situation and the type of medication being administered. When this alarm triggers, the pump must be power cycled to clear the alarm.
To date, Smiths Medical has not received any reports of serious injuries or deaths related to this issue.
Device Use
The CADD-Solis Ambulatory Infusion Pump is intended for use in hospital or outpatient settings. In the hospital, the CADD-Solis Ambulatory Infusion Pump may be used for pain management therapies, including, but not limited to post-operative, trauma, critical care, labor and delivery, general acute care, oncology, and regional anesthesia and analgesia.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Smiths Medical at globalcomplaints@icumed.com or 1-866-216-8806.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
-
Content current as of:
06/03/2025
