FDA Medical Device Safety

Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to Diminished Battery Life that May Impact Infusion Delivery

KCER Release Date: August 20, 2024

To: KCER Distribution list- including ESRD Network EDs and QIDs

This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

• Product Names: Replacement batteries for Plum 360 Infusion System

• Battery List Numbers:
  • Plum 360: SUB0000864

  • Plum A+ and Plum A+3: SUBSUB0000864; SUB0000594
    • Preventing Adult Blood Culture Contamination: A Quality Tool for Clinical Laboratory Professionals

    • Blood Culture Contamination: An Overview for Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory

The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.

What to Do

There is no need to return or discontinue use of Plum 360 or Plum A+ pumps.

For clinical users: 

• Keep the pump plugged into AC power whenever possible.

• Make sure 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 make sure there is enough battery power to keep the pump 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 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:

Biomedical engineering: 

• Replace batteries when the pump triggers a replace battery alarm.

• Do not use replacement batteries with corroded battery terminals.

• Make sure all users of these pumps are immediately made aware of this notification and the updated battery instructions.

• Complete and return the Response Form to icumedical5967@sedgwick.com within ten days.

Distributors:  

• Forward the notice to any customers who may have received it.

• Request that they complete the Response Form and return it to icumedical5967@sedgwick.com.

Reason for Updates to Use Instructions 

ICU Medical is updating the use instructions for the Plum 360, Plum A+ and Plum A+3 Infusion Systems due to a manufacturing defect of the batteries, which can result in the life of the battery to substantially diminish. This updated notice expands affected products from a March 2023 notice and now includes all replacement batteries manufactured by CSB.

The use of affected products may cause serious injury or death to patients due to interruption, under-infusion, or delays in the delivery of critical fluids, blood products, and medications.

There has been one reported injury. There have been no reports of death.

Device Use

The Plum 360, Plum A+ and Plum A+3 Infusion Systems are large volume infusion pumps used to give fluids to patients in precisely controlled infusion amounts and rates. The system delivers blood or blood products, drugs, and other fluid mixtures through subcutaneous, intramuscular, intravenous, and intrathecal administration.

The batteries and replacement batteries are used when the pump is not plugged into AC power, for example when a patient is being transported.

Contact Information 

Customers in the U.S. should report adverse events or product complaints to Global Complaint Management: 1-844-654-7780 or ProductComplaintsPP@icumed.com. For additional information or other assistance, contact Technical Assistance, 1-800-241-4002, option 3. 

Additional FDA Resources 

• ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery [03/23/2023]

• FDA Enforcement Reports
  • Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System

  • Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems

• Medical Device Recall Database entries
  • Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System

  • Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?

• AccessGUDID database - Identify Your Medical Device

• Benefits of a UDI System

How do I report a problem? 

Health care 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.