Medical Device Network

Smiths Medical issues correction for infusion pumps

The FDA recently classified Smiths recall of its CADD-Solis and CADD-Solis VIP ambulatory infusion pumps as Class I.

A medical device correction has been issued by Smiths Medical for its CADD-Solis and CADD-Solis VIP infusion pumps due to software issues.

The recall, which involves correcting devices and not removing them from the market, affects older software versions that have been linked to multiple operational failures. These failures include malfunctioning alarms and detection systems.

In a letter from 27 February 2024, Smiths informed customers that the company was correcting software for the two pumps after it was found that issues may occur when using CADD-Solis and CADD-Solis VIP without the latest software versions.

The company said that many of the issues included in the correction have already been fixed through previous software updates and the corrections will be carried through all subsequent releases. According to the FDA, there has been one reported injury and no reports of death.

The CADD-Solis and CADD-Solis VIP infusion pumps are indicated for intravenous (IV) infusions to deliver precise doses of medication or fluids to patients, either continuously or intermittently. The pumps are employed in settings such as hospitals and home care.

According to a GlobalData market model, the infusion pump market was worth $970m in 2023 and will generate $1.5bn in 2033.

This follows a Class I recall of Smith’s transport ventilators in April 2024. The recall, which involved more than 2,900 emergency ventilators, came after 177 reports of device issues and eight injuries related to the Pneupac Parapac Plus ventilator kits.

Smiths Medical became part of ICU Medical back in January 2022 in a $2.35bn takeover. The purchase has caused a few issues for ICU Medical, including a 2021 warning letter from the FDA for inadequate procedures for handling medical device reports (MDRs), faulty handling of complaints, inadequate validation processes, and lax corrective and preventative actions (CAPA) procedures.

Last month, Abbott announced a voluntary medical device correction for a limited number of FreeStyle Libre 3 sensors in the US. The FreeStyle Libre 3 system includes a sensor, reader, and app to measure glucose. The correction, which impacts only the sensor component, was due to potential inaccurate readings for diabetes patients.