Smiths Medical announced that it has become aware of an issue in which certain Medfusion syringe pumps may not operate as expected.
Minneapolis-based Smiths Medical said in a news release that certain Medfusion 3500 and 4000 syringe pumps with specific firmware versions may provide over-delivery or under-delivery of a bolus or loading dose when one of those doses is interrupted, followed by a specific sequence of events due to a software error. The issue could result in serious injury or death.
Affected models include the Medfusion 3500 syringe pump with firmware version 6.0.0 and the Medfusion 4000 syringe pump with firmware versions 1.5.0, 1.5.1, 1.6.0, 1.6.1 and 1.7.0. The FDA designated a recall of the devices as Class I, the most serious kind.
Smiths Medical distributed the affected models between 2013 and 2020. The company received four reports associated with the issue, all of which involved over-delivery of medication. One report resulted in a serious injury, while no deaths have been reported.
On those specific pumps, the firmware version may be identified by powering them on and observing the firmware version displayed on the screen. Clinicians are instructed to cancel the bolus or loading dose and begin a new infusion if they are interrupted and mechanically primed.
