Plum Solo and Plum Duo Precision IV Pumps
Brand(s)
Summary
Please contact ICU Medical, device correction inquires, regaring this action: https://icumed.custhelp.com/app/marketaction
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
| ICU Medical, Inc. |
| 600 North Field Drive, Lake Forest, Illinois, United States, 60045 |
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