Health Products

Plum Solo and Plum Duo Precision IV Pumps

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Plum Solo and Plum Duo Precision IV Pumps
Issue: Medical devices - Performance
What to do: Please contact ICU Medical, device correction inquires, regaring this action: https://icumed.custhelp.com/app/marketaction
Audience: Healthcare
Recall class: Type II
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Products

Affected prodcutsLot or serial numberModel or catalogue number
Plum Solo Precision IV PumpLogiciel: V1.0.340001-04-01
Plum Duo Precision IV PumpLogiciel: V1.2.340002-04-03

Issue

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.

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