Hospira has issued Urgent Device Recall on Plum A+™ Family of Infusers.
The manufacturer has received customer reports involving two safety issues: (1) rebooting of the infusion pumps, and (2) the incorrect seating of the regulatory closer potentially causing unrestricted flow.
The first issue is related to the continuous recycling and/or rebooting of Plum A+ devices when the "Backlight Intensity" and/or "Display Contrast" settings for the LCD display have been adjusted from default setting. This condition can cause a delay in therapy because the clinician would not be able to start the device due to the continuous recycling and/or rebooting.
The second issue is related to incorrect seating of the regulator closer that potentially causes unrestricted flow of the infusion pump when the cassette door is opened. The condition may lead to life-threatening adverse events.
To correct the issues, Hospira will provide software upgrade and technical checkups to affected customers.
According to the local supplier, Plump A+ infusion pumps have been distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.