ICU Medical recalls Plum 360 Infusion Systems with software v15.10.00.010 due to potential pump lockout during alarms and unresponsive device after 1,500 hours of use.
(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
ICU Medical is recalling Plum 360 Infusion Systems with software version 15.10.00.010 because they can malfunction when alarms occur while paused or become unresponsive after 1,500 hours of use. This could prevent safe delivery of medication if the pump locks up.
The pump may lock up when an alarm occurs while paused, preventing safe shutdown or restart. After 1,500 hours of use, the device becomes unresponsive in service mode and requires power cycling to function.
Healthcare professionals using the Plum 360 Infusion System with software version 15.10.00.010 are most at risk. Patients receiving IV treatments through this system could be affected if the device malfunctions.
Check for software version 15.10.00.010 on the Plum 360 Infusion System. This recall applies to all devices with this specific software version.
Verify the software version on your Plum 360 Infusion System to confirm if it is 15.10.00.010.
The recall is due to potential pump lockup during alarms while paused and device unresponsiveness after 1,500 hours of use.
Check for software version 15.10.00.010 on your Plum 360 Infusion System.
The recall record does not specify a remedy, so contact ICU Medical for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0101-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0101-2018 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
