Smiths Medical Revises CADD-Solis Li-ion Battery Pack Guidelines Following Potential Damage Risks That Could Lead to Circuit Shorts and Impede Recharging
This recall pertains to revised usage guidelines for specific medical devices, rather than their removal from the market or distribution points. The FDA categorizes this recall as the most severe type, indicating that failure to adhere to the new instructions could potentially result in significant injuries or even fatalities.
Product Details
- Product Designation: CADD-Solis Rechargeable Battery Packs
- Model Number: 21-2160-XX
- Lot/Serial Identifiers: All lot and serial identifiers
Recommended Actions
- Inspect the external casing of the affected battery packs for any signs of damage.
- If any battery packs show signs of damage, do not utilize them.
- Damaged packs should be replaced with another rechargeable pack or utilize four AA batteries before proceeding with use.
On July 16, 2024, Smiths Medical issued an Urgent Medical Device Correction letter to all impacted users outlining the following steps:
- Notify all users and potential users of the CADD-Solis rechargeable battery packs about the advisory.
- Inspect battery packs for external damage.
- Never operate a battery pack that appears compromised, according to the usage instructions.
- Replace any defective rechargeable batteries with another CADD-Solis rechargeable or four AA batteries.
- Report damaged batteries via complaint submissions to globalcomplaints@icumed.com or call: 1-866-216-8806.
- Complete and return the attached response document to mailto:smithsmedical5437@sedgwick.com within 10 days, even if no affected items are present. Contact a local representative for credit.
- Distributors are required to inform any customers who may possess potentially impacted products and urge them to fill out the response form.
Rationale Behind Instruction Updates
The updates to the usage instructions for CADD-Solis Li-ion Rechargeable Battery Packs come from concerns regarding the potential for battery pack damage leading to a short circuit. This short could produce excessive heat, resulting in the melting of the battery casing and preventing it from charging.
Utilization of the affected devices could lead to severe health risks, including burns, interruptions in necessary therapy, and possibly death.
As of now, no injuries or deaths have been reported related to this issue.
Device Functionality
CADD-Solis Li-ion Rechargeable Battery Packs serve as an alternative power source for the CADD-Solis ambulatory infusion pump.
The CADD-Solis ambulatory infusion pumps are approved for administerinfusions directly into blood vessels (intravenous), beneath the skin (subcutaneous), within the abdominal cavity (intraperitoneal), near nerves, during surgical procedures (intraoperative), and between spinal vertebrae (epidural or subarachnoid spaces). They are utilized for therapies requiring continual infusions and/or intermittent larger doses (bolus), and/or patient-controlled dosages on demand.
Contact Information
U.S. customers seeking further information about this recall may reach out to Technical Support at TSC.Support@icumed.com or call 1-800-241-4002, option 3.
Additional Resources from the FDA
Unique Device Identifier (UDI)
The unique device identifier (UDI) enables the identification of individual medical devices within the United States, tracking them from manufacturing through distribution to patient application. The implementation of UDI aids in the precise reporting, reviewing, and analyzing of adverse event records, ensuring quicker identification and resolution of issues.
How to Report Issues
Healthcare professionals and consumers are encouraged to report adverse reactions or quality concerns linked to these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.