The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Plum A+ Single Channel Family of Infusers, manufactured by Hospira, Inc. The affected list numbers were 11005, 11971, 12391 and 20792.
Hospira issued a field safety notice to inform users that the volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operation Manual; the direction for" Loud" and "Quiet" may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
In the event the healthcare professional rotates the volume control knob in the direction described in the System Operation manual, the audible tone may be the opposite of the desired audio level. While the device will continue to alarm with an audible one of at least 50 dBA at the lowest level, inadvertently setting a low tone when a louder level is actually intended may result in an audible alarm that is more difficult to hear. If this happens, it is possible the clinician may not be alerted when an alarm condition occurs and an interruption in therapy may occur.
To correct the issue, Hospira will update the system operating manual to clarify the instructions for setting the volume. Furthermore, Hospira will be creating a volume directional label as an additional improvement.
For details, please visit the following MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON199544
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 6 November 2012