On May 22, 2023, the U.S. Food and Drug Administration (FDA) reported ICU Medical’s recall of replacement batteries for its Plum 360™, Plum A+™, and Plum A+3 infusion systems because of a manufacturing defect that can substantially diminish how long the batteries can run the system. FDA identified it as a class I recall, the most serious type of recall, where use may cause serious injuries or death.
In the recall, ICU Medical said that if the pump is running on battery power without an AC power backup, the system may stop an ongoing infusion and power down sooner than expected. The issue may cause serious injury or death to patients because of interruptions, underinfusions, or delays in delivery of critical fluids, blood products, and medications.
To date, ICU Medical received 54 reports about the issue in the Plum 360 system and 465 for the Plum A+/A+3 systems. However, none of the reports involved injuries or deaths. The recall affects 1,904 systems distributed from February 7, 2022–December 22, 2022.
The affected battery list numbers are:
- Plum 360: SUB0000864
- Plum A+ and Plum A+3: SUB0000594
On March 22, 2023, ICU Medical sent an urgent medical device correction letter to customers with recommendations for the recall.
For clinical users, ICU Medical recommended the following actions:
- Keep the pump plugged into AC power whenever possible.
- Ensure the battery is fully charged before disconnecting the pump from AC power.
- Closely monitor the battery status indicator while the pump is disconnected from AC power for its capacity to power the pump.
- Have a backup pump available during all infusions, particularly when infusing critical medications.
- If a pump displays the replace battery alarm, continue the infusion with a different pump and remove the pump from clinical use until the battery is replaced.
For biomedical engineering, ICU Medical recommended the following:
- Identify all affected batteries and ensure all users or potential users are immediately made aware of the recall and proposed mitigations.
- Replace the affected batteries with a new battery until corrected batteries are available. 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 to icumedical5967@sedgwick.com within 10 days of receipt to acknowledge understanding of the notification. If you did not receive the letter and have devices affected by the recall, contact icumedical5967@sedgwick.com or the distributor.
For distributors, immediately forward the notice to customers who have potentially affected products and request that they complete the response form and return it to icumedical5967@sedgwick.com.
ICU Medical said that it will replace all affected batteries and will contact customers when batteries are available to schedule a battery replacement. FDA said ICU Medical’s actions adequately mitigate the risks until a more permanent correction can be made.
To report adverse events or product complaints, contact global complaint management at
844-654-7780 Monday–Friday, from 8 am–5 pm CST, or ProductComplaintsPP@icumed.com. For additional information, contact technical assistance at 800-241-4002, option 3, Monday–Friday, from 8 am–6 pm CST.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experience using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.