In August 2024, the U.S. Food and Drug Administration (FDA) announced that ICU Medical issued an update recall to the use instructions for its Plum 360, Plum A+ and Plum A+3 infusion systems because of a manufacturing defect that can substantially diminish the life of the batteries. ICU Medical’s latest notice expands the affected products from a March 2023 notice to include all replacement batteries manufactured by CSB.

FDA update

ICU Medical said that use of the affected products may cause serious injury or death to patients because of interruption, underinfusion, or delays in the delivery of critical fluids, blood products, and medications. The company said it received one reported injury and no reports of death.

The FDA pointed out that the recall involves updating instructions for using certain devices, not removing them from where they are used or sold. The FDA identified it as a class I recall, the most serious type of recall, where use of the device may cause serious injury or death without following the updated instructions.

The batteries and replacement batteries are used when the pumps are not plugged into AC power (e.g., when a patient is being transported). The following replacement batteries for Plum 360 Infusion Systems are affected:

  • Plum 360: SUB0000864
  • Plum A+ and Plum A+3: SUBSUB0000864; SUB0000594

ICU Medical reiterated that “there is no need to return or discontinue use of Plum 360 or Plum A+ pumps”; however, clinical users like oncology nurses should:

  • Keep the pump plugged into AC power whenever possible.
  • Ensure the battery is fully charged before disconnecting it from AC power.
  • Closely monitor the battery status indicator when the pump is disconnected from AC power to ensure the pump has enough battery power to keep operating.
  • Have a backup pump available when infusing critical medications.
  • If an alarm sounds to replace the battery, continue the infusion with a different pump and remove the alarmed pump from clinical use until the battery is replaced.

On May 7, 2024, ICU Medical sent all affected customers an updated urgent medical device correction letter recommending the following additional actions:

  • Replace the batteries when the pump triggers a replace battery alarm.
  • Do not use replacement batteries with corroded terminals.
  • Ensure all users or customers are immediately made aware of this notification and the updated battery instructions.
  • Complete and return the response form to icumedical5967@sedgwick.com within 10 days.

ICU Medical said that its U.S. customers should report adverse events or product complaints to Global Complaint Management at 844-654-7780 or ProductComplaintsPP@icumed.com. For additional information or other assistance, contact the company’s technical assistance at 800-241-4002, option 3.

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.