Plum Solo and Plum Duo Precision IV Pumps (Plum Solo model 40001-04-01, software V1.0.3; Plum Duo model 40002-04-03, software V1.2.3) are affected. Internal testing found that if a programmed bolus violates a soft limit the pump may not show the bolus soft limit alert before confirming and starting delivery (the soft limit icon appears only after the bolus starts; hard limits still function). Owners should contact ICU Medical device correction inquiries at https://icumed.custhelp.com/app/marketaction.
What's being recalled
Companies: ICU Medical, Inc., 600 North Field Drive, Lake Forest, Illinois, United States, 60045.
How to identify it
Affected prodcuts: Plum Solo Precision IV Pump; Lot or serial number: Logiciel: V1.0.3; Model or catalogue number: 40001-04-01
Affected prodcuts: Plum Duo Precision IV Pump; Lot or serial number: Logiciel: V1.2.3; Model or catalogue number: 40002-04-03
The hazard
Internal testing revealed that under certain conditions, the pump may not display a soft limit alert. LifeShield infusion safety software provides the option to define the maximum dose for the infusion, enable bolus delivery, and define hard and soft limits for the bolus. If the clinician programs a bolus delivery with a medication ruleset that has a maximum dose and bolus soft limits (either lower or upper) defined, and the programmed bolus violates a soft limit, the pump does not notify the clinician of the soft limit violation before confirming and starting delivery.
In this scenario, the pump allows the clinician to confirm and start the bolus without displaying the bolus soft limit alert pop-up, and the dose soft limit icon does not appear on the confirmation screen. The pump does display the soft limit icon on the delivery screen once the bolus starts. Hard limits continue to function as expected.
What to do
Please contact ICU Medical, device correction inquires, regaring this action: https://icumed.custhelp.com/app/marketaction
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)