Smiths Medical has recalled ambulatory infusion pumps to provide updated use instructions to providers after identifying issues with potential false alarms as well as two other problems that could pose safety risks.
The Food and Drug Administration classified each of them as Class I recalls, its most serious type. Smiths Medical has not reported any serious injuries or deaths related to these issues, but the FDA determined there is a risk of harm. The devices are staying on the market.
Issues with Smiths Medical's CADD-Solis and CADD-Solis VIP ambulatory infusion pumps could delay or interrupt treatment, the FDA said.
ICU Medical’s Smiths Medical began notifying healthcare providers about the separate issues in early April.
Smiths Medical said it identified an issue where the CADD-Solis pump, under certain conditions, may trigger an erroneous Upstream Occlusion (USO) Alarm. The erroneous USO alarm may occur when there is a delay of more than one hour between the first prime or infusion of a new CADD Administration Set and the next prime or infusion of the same CADD Administration Set.
The USO Alarm is a high-priority alarm that will interrupt an ongoing infusion or delay initiation of an 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, Smiths Medical said.
Healthcare providers cannot resume or start an infusion until the alarm is cleared, the company said.
The company identified four conditions that may trigger the pump to issue a false alarm. It shared instructions on how to clear the alerts.
Smiths Medical also identified three issues associated with the potential for thermal damage in affected infusion pumps. If certain parts of the pump are damaged, heat can melt the plastic housing to the rechargeable battery pack and the wireless communication module or could cause an electrical short.
The company encouraged customers to inspect their pump's battery packs, battery compartments and wireless communication modules to check for evidence of physical damage. If a battery pack housing is cracked or otherwise damaged, customers should replace the battery pack.
Users would be alerted with the normal “low battery” or “depleted battery” alarms. The presence of excessive heat from damaged or shorted components is also possible, which may result in a thermal injury.
Damage to or inoperable batteries may lead to a delay in therapy or interruption of therapy.
And, the company also identified a third separate network compatibility issue with the CADD-Solis pumps that could interrupt an infusion.
These infusion 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 could trigger a high-priority alarm, which will stop an ongoing infusion.
Smiths Medical provides instructions on how to clear the alarm.
The company also urged healthcare providers to validate any wireless network changes or updates to hospital network settings with the pump/= and communication module to ensure compatibility of the wireless connection before deploying network setting changes or updates to the production environment.