ICU Medical is recalling infusion system 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 with these infusion system replacement batteries 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. The FDA has identified this as a Class I recall, the most serious type of recall.
ICU Medical has received 54 complaints for the Plum 360 and 465 complaints for the Plum A+ and A+3 regarding this issue and has not reported any injuries or deaths. However, according to a release, the FDA has identified an adverse event that may be related to the recall issue.
Actions for Biomedical Engineering
On March 22, 2023, ICU Medical sent an Urgent Medical Device Correction letter to customers with the following recommendations for biomeds:
- 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 protected] 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 icumedic[email protected] or your distributor for further information.