Smiths Medical has issued a Class I recall for certain CADD-Solis and CADD-Solis VIP ambulatory infusion pumps due to multiple issues that could interrupt or delay medication delivery.
The FDA classified the recalls as the most serious type, stating that use could result in serious injury or death, though it does not recommend removing the devices from where they are being used or sold, according to a news release from the agency.
The recalls address three device concerns:
- False occlusion alarms: Under specific conditions, the pumps may trigger a false “upstream occlusion” alarm, which halts therapy. This can occur when there is a delay of more than one hour between priming or infusion steps using the same administration set.
- Thermal damage risk: Internal damage to the battery pack or wireless communication components could lead to overheating. While battery failure could trigger standard alarms, the resulting heat from shortened components could pose a burn risk to users.
- Wireless connectivity issues: Network changes can cause the pump’s wireless module to lose connection, resulting in a high-priority alarm and interruption of infusion.
No serious deaths or injuries have been reported, the release said.
