The FDA has issued a notice classifying a recall of infusion pumps from Smiths Medical as Class I, the most serious kind.
Smiths Medical — which was acquired by ICU Medical in January for $2.35 billion — earlier this month issued a warning in Europe for the same reason: eight potential issues with its Medfusion 3500 and 4000 infusion pumps.
The issues include false alarms, unanticipated depleted battery alarms and abnormal circuit board behavior causing internal clock system failure. Additionally, issues with intermittent volume over time delivery mode means infusion may continue after system failure, while there are issues with the clearing of program volume delivered, incorrect bolus or loading dose time display and network configuration affecting pump communciations.
So far, Smiths Medical has recalled 118,055 devices in the U.S. Those devices were distributed between October 2004 and February 17, 2022, with the firm initiating the recall on April 19, 2022. Across the eight potential issues laid out by Smiths Medical, the company has received seven reports of serious injury and one death, according to the FDA notice. That number is the same as reported on the urgent field safety notice in Europe earlier this month.
Five of the eight potential problems with the Medfusion 3500 and 4000 infusion pumps have not resulted in reported injury or death to date. The three that have produced such reports are the false alarm for the primary audible alarm (PAA) system failure, the unanticipated depleted battery alarms and the intermittent volume over time delivery mode issue.
Smiths Medical has instructed anyone affected by the recall to locate all affected pumps in their possession and ensure all users or potential users are made immediately aware of the notification and the proposed mitigations. The Medfusion operator’s manual instructs users to ensure that, if they are using the device to deliver life-sustaining medications, there is an additional pump available for situations in which an interruption in infusion could be dangerous. If the infusion can’t be resumed with Medfusion, users should use a different pump to continue the infusion.
The company said it intends to address the issues through upcoming software releases. It will update affected pumps that are within their service life at no charge.