Health product recall

Plum Solo and Plum Duo Precision IV Pumps

Last updated

Summary

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

Affected products

Affected prodcuts Lot or serial number Model or catalogue number
Plum Solo Precision IV Pump Logiciel: V1.0.3 40001-04-01
Plum Duo Precision IV Pump Logiciel: V1.2.3 40002-04-03

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. 
 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
ICU Medical, Inc.
600 North Field Drive, Lake Forest, Illinois, United States, 60045
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82074

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