Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today.

The FDA has labeled the recall as Class I, it’s most serious designation.

The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner. They are used primarily in neonatal and pediatric populations in operating rooms, as well as intensive care units for adults.

Smiths Medical became aware of a software issue in the recently updated Firmware Version 1.7.0 for the Medfusion 4000. The issue potentially causes low battery alarms to cease working, which means a user will not receive audible or visual notification that the battery is shutting down.

If the alarm doesn’t sound and the battery shuts down, it could lead to an interruption of therapy that could cause serious injury, adverse events or death. However, no injuries or deaths have been reported, despite 74 complaints related to the software issue.

The model numbers for the affected products are 4000-0107-01 and 4000-0106-01. The affected syringe pumps were manufactured on June 25, 2019, and distributed between Sept. 27, 2019, and Oct. 31, 2019. Smiths Medical has recalled 627 devices in the U.S. since initiating the recall on Oct. 28, 2019. Users are urged to immediately return all affected products.

The Medfusion syringe pumps have been recalled before. In August 2017, the company warned of a defect in certain models of the Medfusion 3500 and Medfusion 4000 models that can cause an “invalid syringe size” alarm to go off. In January 2018, the company amended that recall to include an option for facilities with trained staff to perform the repair onsite.