Smiths Medical notified customers of 50,743 syringe pumps of a software issue that can cause serious injury or death, the FDA said Feb. 14.
An earlier software version of the product, the Medfusion Model 4000 Syringe Infusion Pump, might disrupt therapy administration and affect the alarm system, pump, control screen and other parts. To date, one injury and zero deaths have been reported.
To avoid the issue, Smiths Medical recommends customers confirm the pumps have the most recent Medfusion software installed.