The FDA is warning consumers that CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps are in need of software corrections due to multiple problems that have been identified in outdated software.
Initiated by Smiths Medical, the recall has been labeled in an August 6, 2024 post on the FDA site as Class I, the most serious type, because use of the product on the outdated, uncorrected software may lead to serious injury or death.
CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps are indicated for multiple applications:
- Intravenous infusions (in blood vessels) via
- the arteries (intra-arterial),
- under the skin (subcutaneous),
- through the abdomen (intraperitoneal)
- near the nerves,
- through a surgical site (intraoperative),
- and in the spine, between vertebrae (“epidural space/subarachnoid spaces”).
- Other treatments requiring:
- Continuous infusion rates, and/or
- an intermittent larger dose (bolus), and/or
- on-demand doses controlled by the patient.
Officials noted that this particular recall does not require a removal of the devices from where they are currently implemented or sold, but calls for a software update in the following specific CADD-Solis Ambulatory Infusion Pumps:
- 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
According to Smiths Medical, previous software updates have addressed many of the issues presented in the correction, and the corrections have been applied to “all subsequent software releases.”
The August 6, 2024, FDA communication includes a list of issues identified throughout the affected devices with outdated software:
- No alarm indicating an upstream occlusion
- Unresponsive Stop and Power keys
- Manual mode does not have an air detector
- No alarm when a single bubble air is detected
- When powered on, error codes are not displayed
- No alarm sound is audible
- Threshold for “air in line” detection could potentially be too high
- server password failure in PharmGuard
Consumers are advised that using the recalled devices without the proper software updates may cause therapy to be delayed, interrupted, as well as under- or over-administered, which could lead to major adverse health outcomes, even death.
To date of the FDA announcement, the company has been alerted to one report of a related injury, and no reports of death.
An Urgent Medical Device Correction Letter sent to all impacted Smiths Medical customers on February 27, 2024, listed the following recommendations:
- Users:
- Identify all pumps affected by the recall
- Ensure that all users and potential users have read the notice and are aware of the necessary corrections.
- Within 10 days of receipt, even if no affected product has been identified at the facility, fill out ad submit the response form (attached to the Urgent Medical Device Correction Letter) via email to smithsmedical3563@sedgwick.com.
- Distributors:
- Ensure that all customers who may have received potentially affected devices are notified by sending them the letter.
- Instruct those customers to fill out and submit their own response form to smithsmedical3563@sedgwick.com.
As the FDA continues to closely follow this recall, healthcare professionals and consumers alike are aked to report any related adverse experiences to the agency’s MedWatch program.
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