FDA says Smiths Medical drug-infusion pump recall is Class 1

The Food and Drug Administration has classified a recall of about 600 pediatric drug-infusion pumps made by Plymouth-based Smiths Medical as a Class 1 recall, meaning that a software problem in the pumps could lead to injuries or death.

In October, Smiths Medical contacted customers about a software problem that triggered a focused recall of 626 specific devices that were initially sent to customers in three states: Colorado, New York and Maryland. The affected devices were Medfusion 4000 Syringe Pumps with Firmware Version 1.7.0. ("Firmware" is software intended to permanently reside on a computer to make a device work.)

Medfusion 4000 syringe pumps are portable devices widely used in children's hospitals and neonatal intensive-care units as well as in operating rooms and adult critical care units, Smiths Medical said.

A drug-infusion pump is a machine that continuously moves medications into a patient's IV line at a specific rate, and can be programmed to deliver drugs over a period of time. A syringe pump like the Medfusion 4000 is a type of pump that takes small amounts of medication directly from a syringe, instead of from a large, clear bag hanging on a rod at the patient bedside.

Smiths said the Medfusion 4000 pump can reliably deliver drug doses as low as 0.01 mL per hour.

The recall announcement said a problem in the 1.7.0 firmware could cause the low-battery alarm to stop working.

"If the battery alarms do not work, the health care provider using the pump will not receive audible or visual notification that the battery is shutting down. This may lead to an interruption of therapy which may lead to serious injury, adverse events, or death," an FDA recall announcement published this week says.

No injuries or deaths have been reported, but Smiths Medical received at least 74 complaints related to the software update. Smiths advised customers in October to locate any affected pumps and send them back to the manufacturer for processing.

If those customers had already distributed any of the potentially affected products to other parties, they were told to contact those recipients and forward a copy of the recall notice as well.

The full list of product serial numbers affected by the recall can be found by searching for the word "Medfusion" in the FDA's database of medical device recalls.

On Dec. 23, Smiths Medical provided a statement to the Star Tribune:

"The Medfusion upgrade had a very limited distribution to three customers. The Smiths Medical technical team became aware of a potential issue that could, under a very specific set of circumstances, lead to a failure of the pump. Smiths Medical has received no reports of loss of battery alarm functionality or interruption of therapy. We followed our standard process of notification to the FDA. Additionally, we followed our standard protocols and are maintaining Smiths Medical's continual focus on patient safety and service that we devote to all our products. The current version of the Medfusion Pump (v1.6) is available and continues to be used, successfully supporting patient care as one of our market leading infusion products."

Joe Carlson • 612-673-4779