On February 14, 2024, the U.S. Food and Drug Administration (FDA) reported Smiths Medical ASD Inc.’s recall of its Medfusion model 4000 syringe pump because of issues associated with earlier software versions that may affect the alarm system, the pump, the control screen, and other parts of the pump. If undetected issues are present in the device, the device has the potential to fail and delay, interrupt, or fail to deliver the therapy per the programmed setting.

FDA update

FDA said that it has received reports of one injury and no deaths related to this issue. The agency identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

The recall affects 50,743 Medfusion Model 4000 syringe pumps (product codes FRN), which were distributed in the United States from November 16, 2010–July 28, 2023. The affected pumps may have the following issues:

  • Delivery during motor not running high priority alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2)
  • Re-administered loading dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2)
  • Incorrect critical data failure alarm
  • Interruption of bolus or loading dose delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2)
  • Incorrect total bolus/loading dose displayed (v1.1.0, v1.1.1, v1.1.2)
  • Volume limit before bolus/loading dose complete (v1.1.2)
  • Drug library lower limit displayed incorrectly (v1.6.0, v1.6.1)
  • Depleted battery alarm (all versions previous to v1.6.5)
  • Loss of wireless connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4)
  • PharmGuard server password (v2.3, v2.4, v2.5)

On December 19, 2023, Smiths Medical sent an urgent medical device correction letter requesting customers to:

  • Locate all affected pumps and ensure all users are immediately made aware of the notification and proposed mitigations.
  • Confirm all pumps have the most recent Medfusion software installed.
  • Complete the response form provided and return to smithmedical6114@sedgwick.com within 10 days of receipt of the letter.

Customers with questions about the recall should contact Smiths Medical at 866-216-8806. Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.