Ambulatory Infusion Pump Software Correction: Smiths Medical Issues Correction for CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump Software due to Multiple Issues Related to Outdated Software

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

• Product Names: 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
• Unique Device Identifier (UDI)/Model: See full list of affected products

What to Do

• Make sure the most recent CADD software is installed on all pumps.

Smiths Medical corrected many of the issues included in correction through previous software updates and the corrections were carried forward into all subsequent software releases.

On February 27, 2024, Smiths Medical sent all affected customers an Urgent Medical Device Correction Letter recommending the following actions:

For users

• Locate affected pumps.
• Make sure all users or potential users are aware of the notice and corrections.
• Complete and return the response form attached to the letter to smithsmedical3563@sedgwick.com within 10 days even if there is no affected product.

For distributors

• Forward notice to any customers who may have received potentially affected products.
• Request they complete the response form and return it to smithsmedical3563@sedgwick.com.

Reason for Correction

Smiths Medical is correcting software for CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to multiple issues that may occur when using these infusion pumps without the latest software versions. The potential issues may happen with software versions before v4.3 and include:

• Failure to alarm when there is an upstream occlusion
• Unresponsive stop and power keys
• Air detector fails to start in manual mode
• Failure to alarm 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

The use of affected products may cause serious adverse health consequences related to delay, interruption, under- or over-administration of therapy, or death.

There has been one reported injury and no reports of death.

Device Use

The CADD Solis and CADD Solis VIP Ambulatory Infusion Pumps are indicated for the following uses:

• For infusions in blood vessels (intravenous) including arteries (intra-arterial), under the skin (subcutaneous), into the abdomen (intraperitoneal), close to nerves, into a surgical site (intraoperative), between vertebrae in the spine (epidural space or subarachnoid spaces).
• Treatments that require continuous infusion rates and/or an intermittent larger dose (bolus), and/or patient-controlled on-demand doses.

Contact Information

Customers in the U.S. with questions about this recall should contact Technical Support at TSC.Support@icumed.com or 1-800-241-4002, option 3, 4.

Full List of Affected Devices

Additional FDA Resources:

• FDA’s Enforcement Reports
  • Model 2110:
    https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=206607
  • Model 2100:
    https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=206603
  • Model 2120:
    https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=208401
• Medical Device Recall Database entries
  • Class 1 Device Recall smiths medical CADD Solis Model 2110
  • Class 1 Device Recall smiths medical CADD Solis Model 2100
  • Class 1 Device Recall smiths medical CADD Solis Model 2120