The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems
- Battery List Numbers:
- Plum 360: SUB0000864
- Plum A+ and Plum A+3: SUB0000594
- Devices Recalled in the U.S.: 1,904
- Dates Distributed: February 7, 2022 – December 22, 2022
- Date Initiated by Firm: March 22, 2023
The Plum 360, Plum A+ and Plum A+3 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.
Reason for Recall
ICU Medical is recalling replacement batteries for the Plum 360, Plum A+, and Plum A+3 Infusion Systems because a manufacturing defect has substantially diminished how long they can be used to run the system. If the pump is running on battery power and there is no AC power backup available, the system may shut down an ongoing infusion and power down sooner than expected.
This issue 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.
ICU Medical has received 54 (Plum 360) and 465 (Plum A+/A+3) complaints regarding this issue and has not reported any injuries or deaths. However, the FDA has identified an adverse event that may be related to the recall issue.
Who May Be Affected
- People who are treated in a health care setting using the Plum 360, Plum A+, or Plum A+3 Infusion Systems.
- Health care personnel who use Plum 360, Plum A+, or Plum A+3 Infusion Systems to deliver fluids, blood, and medications to patients in health care settings.
What to Do
On March 22, 2023, ICU Medical sent an Urgent Medical Device Correction letter to customers with the following recommendations:
Clinical User Actions
- Keep the pump plugged into AC power whenever possible.
- Ensure the battery is fully charged before disconnecting the pump from AC power (to transport a patient, for example).
- Closely monitor the Battery Status Indicator while the pump is disconnected from AC power to help ensure there is sufficient battery capacity to power the pump.
- Have a backup pump available during all infusions and particularly when infusing critical medications.
- If a Plum pump displays the Replace Battery alarm mentioned above, continue the infusion with a different pump and remove the pump from clinical use until the battery is replaced.
Actions for Biomedical Engineering
- Identify all affected batteries and ensure all users or potential users of these pumps are immediately made aware of this notification and proposed mitigations.
- You may replace affected batteries with a new CSB battery until corrected batteries are available. Please do not use a replacement battery with corroded battery terminals.
- If you received the Urgent Medical Device Correction letter, complete and return the Response Form attached to the letter to email@example.com within ten days of receipt to acknowledge understanding of the notification. If you have not received the Urgent Medical Device Correction letter and have devices affected by this recall, please contact firstname.lastname@example.org or your distributor for further information.
Actions for Distributors
If potentially affected products were distributed to customers, please immediately forward this notice to them. Request that they complete the response form and return it to email@example.com.
ICU Medical will replace all batteries affected by this issue and will contact customers when batteries are available to schedule a battery replacement.
FDA believes the actions above adequately mitigate the risks until a more permanent correction can be made.
To report adverse events or product complaints:
Global Complaint Management
1-844-654-7780 (M-F, 8:00am – 5:00pm CT) or ProductComplaintsPP@icumed.com
Additional information or assistance:
1-800-241-4002, option 3 (M-F, 8:00 am – 6:00 pm CT)
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 using an online form, regular mail, or FAX.